Houston Heart Care Blog | Memorial Katy Cardiology Associates

3 min read

4 Tips to Quit Smoking

By Orville Caval on Aug 20, 2019 12:01:33 PM

Nearly 70 percent of current adult smokers say they want to stop.

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All Gave Some, Some Gave All

By Orville Caval on May 27, 2019 10:33:47 AM

Memorial Day is the time to remember and honor those who risked their lives to protect us and the country. Reach out to your friends, family and loved ones with our Memorial Day wishes filled with pride, warmth and togetherness.

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2 min read

How long should you keep a blood pressure log?

By Orville Caval on May 16, 2019 1:18:21 PM

Routine visits to the doctor’s office typically involve a single blood pressure measurement. For people with borderline hypertension, or high blood pressure, additional checks at the office are often necessary, in conjunction with having more checks done at home. How many exactly?

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5 min read

Is Heart Healthy Diet a Viable Alternative to Drugs to Normalize Blood Pressure?

By Orville Caval on May 12, 2019 10:00:00 AM

Hypertension, otherwise known as high blood pressure, is widespread in the United States. It is approximated that one in every three adults in the United States suffers from high blood pressure, and for adults aged 65 or older, this number climbs to over 60 percent.

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1 min read

Are Meat, Fish, Dairy Products, Eggs in your diet leading you to heart disease?

By Orville Caval on May 10, 2019 9:02:19 AM

Summer is quickly approaching and with it comes grilling season, chances are at least once this summer you’ll wonder about the effects of that delicious, juicy grilled steak will have on your heart?

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1 min read

Nurses Week 2019!

By Orville Caval on May 7, 2019 1:31:31 PM

In 1993, the American Nurses Association declared a national week to celebrate and elevate the nursing profession. Each year, the celebration starts on May 6th and ends on May 12, Florence Nightingale's birthday. The purpose of this week-long celebration is to raise awareness of the value of nursing and help educate the public about the role nurses play in meeting the healthcare needs of Americans. 

Topics: Heart Health
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16 min read

Updated: Voluntary Recall - Losartan Potassium Tablets & Losartan Potassium /Hydrochlorothiazide Tablets

By Orville Caval on May 3, 2019 9:29:51 AM

When a company announces a recall, market withdrawal, or safety alert, MKC posts the company's announcement as a public service. MKC does not endorse either the product or the company.
Read Announcement

 

Summary

Company Announcement Date: March 01, 2019
FDA Publish Date: April 30, 2019
Product Type: Drugs
Reason for Announcement:
Device & Drug Safety, Unapproved Ingredient
Company Name: Torrent Pharmaceuticals Limited
Brand Name:
Torrent Pharma
Product Description: Losartan Potassium Tablets USP and Losartan Potassium/hydrochlorothiazide Tablets USP

Company Announcement

Torrent Pharmaceuticals Limited is voluntarily recalling 60 lots of Losartan potassium tablets USP and 54 lots of Losartan potassium/ hydrochlorothiazide tablets, USP, to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited.

The impurity detected in the API is N-Methylnitrosobutyric acid (NMBA). Torrent is only recalling lots of losartan-containing products that contain N-Methylnitrosobutyric acid (NMBA) above the acceptable daily intake levels released by the FDA.

To date, Torrent Pharmaceuticals Limited has not received any reports of adverse events related to this recall.

Losartan is used to treat hypertension, hypertensive patients with Left Ventricular Hypertrophy and for the treatment of nephropathy in Type 2 diabetic patients. Losartan potassium and hydrochlorothiazide tablets, USP is used to treat hypertension and hypertensive patients with Left Ventricular Hypertrophy.

Patients who are taking Losartan Potassium Tablets, USP and Losartan Potassium/ Hydrochlorothiazide Tablets, USP should continue taking their medication, as the risk of harm to the patient’s health may be higher if the treatment is stopped immediately without any alternative treatment. Patients should contact their pharmacist or physician who can advise them about an alternative treatment prior to returning their medication.

The products subject to recall are listed below. The product can be identified by checking the product name, manufacturer details and batch or lot number on the bottle containing these products.

Losartan Potassium Tablet and Losartan Potassium/ Hydrochlorothiazide Tablet Lots

NDC Finished Product Strength and Package Count Batch Number Expiration Date
13668-113-90 Losartan Potassium Tablets, USP 25mg, 90 count 4DU1E005 1/31/2021
13668-113-90 Losartan Potassium Tablets, USP 25mg, 90 count 4DU1E006 1/31/2021
13668-113-90 Losartan Potassium Tablets, USP 25mg, 90 count 4DU1E008 1/31/2021
13668-113-10 Losartan Potassium Tablets, USP 25mg, 1000 count 4DU1E007 1/31/2021
13668-409-30 Losartan Potassium Tablets, USP 50mg, 30 count 4DU2D077 10/31/2020
13668-409-90 Losartan Potassium Tablets, USP 50mg, 90 count 4DU2D087 10/31/2020
13668-409-90 Losartan Potassium Tablets, USP 50mg, 90 count 4DU2E023 1/31/2021
13668-409-90 Losartan Potassium Tablets, USP 50mg, 90 count 4DU2E024 1/31/2021
13668-409-90 Losartan Potassium Tablets, USP 50mg, 90 count 4DU2E026 1/31/2021
13668-409-90 Losartan Potassium Tablets, USP 50mg, 90 count 4DU2E027 1/31/2021
13668-409-90 Losartan Potassium Tablets, USP 50mg, 90 count 4DU2E028 1/31/2021
13668-409-90 Losartan Potassium Tablets, USP 50mg, 90 count 4DU2E029 1/31/2021
13668-409-90 Losartan Potassium Tablets, USP 50mg, 90 count 4DU2E020 1/31/2021
13668-409-90 Losartan Potassium Tablets, USP 50mg, 90 count 4O50E007 8/31/2021
13668-409-90 Losartan Potassium Tablets, USP 50mg, 90 count 4O50E008 8/31/2021
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2D067 9/30/2020
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2D069 9/30/2020
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2D063 9/30/2020
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2D064 9/30/2020
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2D065 9/30/2020
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2D066 9/30/2020
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2D084 10/31/2020
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2D085 10/31/2020
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2D083 10/31/2020
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2D082 10/31/2020
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2D072 10/31/2020
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2D077 10/31/2020
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2D078 10/31/2020
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2D079 10/31/2020
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2D081 10/31/2020
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2D080 10/31/2020
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2D070 10/31/2020
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2D073 10/31/2020
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2D074 10/31/2020
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2D075 10/31/2020
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2D086 10/31/2020
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2D088 10/31/2020
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2D089 10/31/2020
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2E019 1/31/2021
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2E021 1/31/2021
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2E022 1/31/2021
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2E025 1/31/2021
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2E032 2/28/2021
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2E033 2/28/2021
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2E034 2/28/2021
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2E035 2/28/2021
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2E036 2/28/2021
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2E037 2/28/2021
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2E038 2/28/2021
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2E039 2/28/2021
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2E041 2/28/2021
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2E103 6/30/2021
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2E101 6/30/2021
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2E102 6/30/2021
13668-115-90 Losartan Potassium Tablets, USP 100mg, 90 count 4DU3E014 1/31/2021
13668-115-90 Losartan Potassium Tablets, USP 100mg, 90 count 4DU3E015 1/31/2021
13668-115-90 Losartan Potassium Tablets, USP 100mg, 90 count 4DU3E065 7/31/2021
13668-115-10 Losartan Potassium Tablets, USP 100mg, 1000 count 4DU3D018 11/30/2020
13668-115-10 Losartan Potassium Tablets, USP 100mg, 1000 count 4DU3E062 6/30/2021
13668-115-10 Losartan Potassium Tablets, USP 100mg, 1000 count 4DU3E063 6/30/2021
13668-116-30 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 30 count BEF7D017 6/30/2020
13668-116-90 Losartan Potassium /Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 count BEF7D010 4/30/2020
13668-116-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 count BEF7D011 4/30/2020
13668-116-90 Losartan Potassium /Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 count BEF7D018 6/30/2020
13668-116-90 Losartan Potassium / Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 count BEF7D009 4/30/2020
13668-116-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 count 4P02E002 1/31/2021
13668-116-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 count 4P02E003 1/31/2021
13668-116-90 Losartan Potassium / Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 count 4P02E004 1/31/2021
13668-116-10 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 1000 count BEF7D008 4/30/2020
13668-116-10 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 1000 count BEF7D022 8/31/2020
13668-116-10 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 1000 count BEF7D012 4/30/2020
13668-116-10 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 1000 count BEF7D013 4/30/2020
13668-116-10 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 1000 count BEF7D049 11/30/2020
13668-116-10 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 1000 count 4P02E005 1/31/2021
13668-116-10 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 1000 count 4P02E006 1/31/2021
13668-117-30 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 30 count BEF8D058 11/30/2020
13668-117-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 count BEF8D023 4/30/2020
13668-117-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 count BEF8D024 4/30/2020
13668-117-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 count BEF8D025 4/30/2020
13668-117-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 count BEF8D009 3/31/2020
13668-117-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 count BEF8D010 3/31/2020
13668-117-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 count BEF8D011 3/31/2020
13668-117-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 count BEF8D012 3/31/2020
13668-117-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 count BEF8D013 3/31/2020
13668-117-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 count BEF8D054 10/31/2020
13668-117-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 count BEF8D055 10/31/2020
13668-117-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 count BEF8D056 10/31/2020
13668-117-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 count BEF8D057 11/30/2020
13668-117-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 count BEF8D007 3/31/2020
13668-117-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 count BEF8D008 3/31/2020
13668-117-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 count BEF8D020 4/30/2020
13668-117-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 count BEF8D021 4/30/2020
13668-117-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 count BEF8D022 4/30/2020
13668-118-30 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 30 count BEF6D038 4/30/2020
13668-118-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count BEF6D030 4/30/2020
13668-118-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count BEF6D031 4/30/2020
13668-118-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count BEF6D047 7/31/2020
13668-118-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90count BEF6D048 7/31/2020
13668-118-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count BEF6D049 7/31/2020
13668-118-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count BEF6D050 7/31/2020
13668-118-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count BEF6D051 7/31/2020
13668-118-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count BEF6D082 10/31/2020
13668-118-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count BEF6D083 10/31/2020
13668-118-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count BEF6D084 10/31/2020
13668-118-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count BEF6D085 10/31/2020
13668-118-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count BEF6D086 10/31/2020
13668-118-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count BEF6D087 10/31/2020
13668-118-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count 4P04E003 1/31/2021
13668-118-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count 4P04E004 1/31/2021
13668-118-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count 4P04E005 1/31/2021
13668-118-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count 4P04E006 1/31/2021
13668-118-10 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 1000 count 4P04E007 1/31/2021
13668-118-10 Losartan Potassium/Hydrochlorothiazide Tablets, USP 100mg/25mg, 1000 count 4P04E008 1/31/2021
13668-118-10 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 1000 count 4P04E009 1/31/2021

 

Losartan potassium tablets, USP and Losartan potassium/ hydrochlorothiazide tablets, USP were distributed nationwide to Torrent’s wholesale distributor, repackager and retail customers. Torrent Pharmaceuticals Limited is notifying its distributors and customers by phone and in writing to immediately discontinue distribution of the specific lots being recalled and to notify their sub-accounts. Torrent is arranging for return of all recalled products to Qualanex. Instructions for returning recalled products are given in the recall letter.

Consumers with medical questions regarding this recall or to report an adverse event can contact Torrent Pharmaceuticals Limited at:

  • 1-800-912-9561 (live calls received 8:00 am – 5:00 pm Eastern Time, voicemail available 24 hours/day, 7 days/week).

  • Medinfo.Torrent@apcerls.com

Consumers should also contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Any general questions regarding the return of this product should be directed to Qualanex at 1- 888-280-2040 (live calls received 8 am - 9:00 pm Eastern Time).

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Complete and submit the report Online: www.fda.gov/medwatch/report.htm

Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm

Call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178 


Company Contact Information

Consumers:
1-800-912-9561
Medinfo.Torrent@apcerls.com

 

 

Topics: Drug Recall
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9 min read

Understanding the New 2019 ACC/AHA Guideline on the Prevention of Cardiovascular Disease

By Orville Caval on Apr 29, 2019 4:23:52 PM

Worldwide headlines read: “Aspirin no longer useful for stroke and heart attack prevention”

Source of this buzz was the new guidelines issued from a joint American College of Cardiology and American Heart Association (ACC/AHA) guideline published in early March, 2019. The new guideline is meant solely for primary prevention. Anyone with known clinically significant atherosclerotic vascular disease (ASCVD) is excluded from this guideline as their care is categorized as “secondary prevention”. One may suppose that the only topic in the guideline was aspirin use for the primary prevention of heart attack and stroke. In fact, the recommendations involved other key topics that are summed up here in text and pictures. But first, let’s discuss aspirin.

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33 min read

Updated: Expands Voluntary Nationwide Recall of Losartan Potassium Tablets and Losartan Potassium/Hydrochlorothiazide Tablets

By Orville Caval on Apr 29, 2019 12:00:18 PM

When a company announces a recall, market withdrawal, or safety alert, MKC posts the company's announcement as a public service. MKC does not endorse either the product or the company.

Read Announcement

Topics: Drug Recall
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2 min read

Legacy Pharmaceutical Expands Voluntary Recall of Losartan Tablets, 50mg

By Orville Caval on Apr 25, 2019 10:03:31 AM

When a company announces a recall, market withdrawal, or safety alert, Memorial Katy Cardiology Associates posts the company's announcement as a public service. Memorial Katy Cardiology Associates does not endorse either the product or the company.

Legacy Pharmaceutical Packaging, LLC is expanding its consumer-level recall of 3 repackaged lots Losartan Tablets USP 50mg to include one additional lot. This recall was prompted due to Torrent Pharmaceuticals LTD issuing a Voluntary Nationwide Recall of Losartan Tablets, USP, due to the detection of trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) a possible process impurity or contaminant in an active pharmaceutical ingredient, manufactured by Hetero Labs Limited, (API manufacturer).

NMBA is a potential human carcinogen. To date, Legacy has not received any reports of adverse events related to this recall.

Losartan Potassium USP is a prescription medication used to treat high blood pressure and congestive heart failure and is packaged in 30ct bottles. The identifying NDC number associated with Legacy’s product is as follows:

Losartan Potassium, USP, 50mg NDC 68645-494-54

The affected Losartan Potassium includes 4 repackaged lots numbers (3 initial repackaged lot and 1 expanded repackaged lot) which are listed below:

LEGACY NDC# Name and Strength Count Legacy Lot # Expiry
68645-494-54 Losartan Potassium Tablets USP 50 mg 30 180190 10/2020
68645-494-54 Losartan Potassium Tablets USP 50 mg 30 180191 10/2020
68645-494-54 Losartan Potassium Tablets USP 50 mg 30 181597 02/2021
68645-494-54 Losartan Potassium Tablets USP 50 mg 30 181598 02/2021

The product can be identified by checking the product name and repackaged lot number on the bottle containing these products.

Losartan Potassium was distributed by pharmacies nationwide. Legacy Pharmaceutical Packaging LLC is notifying its distributors and customers in writing and is arranging/assisting for return of all recalled products to Inmar Pharmaceutical Services. Instructions for returning recalled products are provided in the recall letter.

Consumers with questions regarding this recall can contact Inmar at 1-877-538-8443, Monday – Friday, 9am – 5pm EST. Consumers should contact their physician or healthcare provider if they have that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Initial Press Release

Topics: Drug Recall
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2 min read

Have we improved our sedentary behaviors over the past twenty years?

By Orville Caval on Apr 25, 2019 9:53:25 AM

Considering the risks of cardiovascular disease related to sedentary behaviors, the study conducted by Yang L, Cao C, Kantor ED, et al. illustrates concerning—though not surprising— data. Greater effort to reduce sedentary habits together with promotions of regular physical activity are essential to improving public health.

Topics: Heart Health
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27 min read

Updated: Voluntary Recall Losartan & Losartan/Hydrochlorothiazide Tablets

By Orville Caval on Apr 19, 2019 1:24:42 PM

When a company announces a recall, market withdrawal, or safety alert, the MKC posts the company's announcement as a public service. MKC does not endorse either the product or the company.

Torrent Pharmaceuticals Limited is expanding its recall for Losartan Potassium Tablets USP and Losartan Potassium/hydrochlorothiazide tablets, USP, to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited.

The Recall is expanded to include an additional 36 lots of Losartan potassium Tablets USP and 68 lots of Losartan Potassium/Hydrochlorothiazide Tablets, USP

The impurity detected in the API is N-Methylnitrosobutyric acid (NMBA). Torrent is only recalling lots of losartan-containing products that contain N-Methylnitrosobutyric acid (NMBA) above the acceptable daily intake levels released by the FDA.

To date, Torrent Pharmaceuticals Limited has not received any reports of adverse events related to this recall.

Losartan is used to treat hypertension, hypertensive patients with Left Ventricular Hypertrophy and for the treatment of nephropathy in Type 2 diabetic patients. Losartan potassium and hydrochlorothiazide tablets, USP is used to treat hypertension and hypertensive patients with Left Ventricular Hypertrophy.

Patients who are taking Losartan Potassium Tablets, USP and Losartan Potassium/Hydrochlorothiazide Tablets, USP should continue taking their medication, as the risk of harm to the patient’s health may be higher if the treatment is stopped immediately without any alternative treatment. Patients should contact their pharmacist or physician who can advise them about an alternative treatment prior to returning their medication.

The product/lots included in the expanded recall are listed below in red. The product can be identified by checking the product name, manufacturer details and batch or lot number on the bottle containing these products.

Losartan Potassium Tablet &
Losartan Potassium/ Hydrochlorothiazide Tablet Lots

NDC Finished Product Strength and Package Count Batch Number Expiration Date
13668-113-90 Losartan Potassium Tablets, USP 25mg, 90 count 4DU1E005 1/31/2021
13668-113-90 Losartan Potassium Tablets, USP 25mg, 90 count 4DU1E006 1/31/2021
13668-113-90 Losartan Potassium Tablets, USP 25mg, 90 count 4DU1E008 1/31/2021
13668-113-10 Losartan Potassium Tablets, USP 25mg, 1000 count 4DU1E007 1/31/2021
13668-409-30 Losartan Potassium Tablets, USP 50mg, 30 count 4DU2D077 10/31/2020
13668-409-90 Losartan Potassium Tablets, USP 50mg, 90 count 4DU2D087 10/31/2020
13668-409-90 Losartan Potassium Tablets, USP 50mg, 90 count 4DU2E023 1/31/2021
13668-409-90 Losartan Potassium Tablets, USP 50mg, 90 count 4DU2E024 1/31/2021
13668-409-90 Losartan Potassium Tablets, USP 50mg, 90 count 4DU2E026 1/31/2021
13668-409-90 Losartan Potassium Tablets, USP 50mg, 90 count 4DU2E027 1/31/2021
13668-409-90 Losartan Potassium Tablets, USP 50mg, 90 count 4DU2E028 1/31/2021
13668-409-90 Losartan Potassium Tablets, USP 50mg, 90 count 4DU2E029 1/31/2021
13668-409-90 Losartan Potassium Tablets, USP 50mg, 90 count 4DU2E020 1/31/2021
13668-409-90 Losartan Potassium Tablets, USP 50mg, 90 count 4O50E007 8/31/2021
13668-409-90 Losartan Potassium Tablets, USP 50mg, 90 count 4O50E008 8/31/2021
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2D067 9/30/2020
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2D069 9/30/2020
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2D063 9/30/2020
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2D064 9/30/2020
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2D065 9/30/2020
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2D066 9/30/2020
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2D084 10/31/2020
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2D085 10/31/2020
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2D083 10/31/2020
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2D082 10/31/2020
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2D072 10/31/2020
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2D077 10/31/2020
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2D078 10/31/2020
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2D079 10/31/2020
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2D081 10/31/2020
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2D080 10/31/2020
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2D070 10/31/2020
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2D073 10/31/2020
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2D074 10/31/2020
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2D075 10/31/2020
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2D086 10/31/2020
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2D088 10/31/2020
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2D089 10/31/2020
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2E019 1/31/2021
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2E021 1/31/2021
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2E022 1/31/2021
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2E025 1/31/2021
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2E032 2/28/2021
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2E033 2/28/2021
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2E034 2/28/2021
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2E035 2/28/2021
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2E036 2/28/2021
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2E037 2/28/2021
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2E038 2/28/2021
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2E039 2/28/2021
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2E041 2/28/2021
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2E103 6/30/2021
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2E101 6/30/2021
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2E102 6/30/2021
13668-115-90 Losartan Potassium Tablets, USP 100mg, 90 count 4DU3E014 1/31/2021
13668-115-90 Losartan Potassium Tablets, USP 100mg, 90 count 4DU3E015 1/31/2021
13668-115-90 Losartan Potassium Tablets, USP 100mg, 90 count 4DU3E065 7/31/2021
13668-115-10 Losartan Potassium Tablets, USP 100mg, 1000 count 4DU3D018 11/30/2020
13668-115-10 Losartan Potassium Tablets, USP 100mg, 1000 count 4DU3E062 6/30/2021
13668-115-10 Losartan Potassium Tablets, USP 100mg, 1000 count 4DU3E063 6/30/2021
13668-116-30 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 30 count BEF7D017 6/30/2020
13668-116-90 Losartan Potassium /Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 count BEF7D010 4/30/2020
13668-116-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 count BEF7D011 4/30/2020
13668-116-90 Losartan Potassium /Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 count BEF7D018 6/30/2020
13668-116-90 Losartan Potassium / Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 count BEF7D009 4/30/2020
13668-116-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 count 4P02E002 1/31/2021
13668-116-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 count 4P02E003 1/31/2021
13668-116-90 Losartan Potassium / Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 count 4P02E004 1/31/2021
13668-116-10 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 1000 count BEF7D008 4/30/2020
13668-116-10 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 1000 count BEF7D022 8/31/2020
13668-116-10 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 1000 count BEF7D012 4/30/2020
13668-116-10 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 1000 count BEF7D013 4/30/2020
13668-116-10 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 1000 count BEF7D049 11/30/2020
13668-116-10 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 1000 count 4P02E005 1/31/2021
13668-116-10 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 1000 count 4P02E006 1/31/2021
13668-117-30 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 30 count BEF8D058 11/30/2020
13668-117-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 count BEF8D023 4/30/2020
13668-117-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 count BEF8D024 4/30/2020
13668-117-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 count BEF8D025 4/30/2020
13668-117-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 count BEF8D009 3/31/2020
13668-117-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 count BEF8D010 3/31/2020
13668-117-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 count BEF8D011 3/31/2020
13668-117-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 count BEF8D012 3/31/2020
13668-117-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 count BEF8D013 3/31/2020
13668-117-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 count BEF8D054 10/31/2020
13668-117-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 count BEF8D055 10/31/2020
13668-117-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 count BEF8D056 10/31/2020
13668-117-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 count BEF8D057 11/30/2020
13668-117-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 count BEF8D007 3/31/2020
13668-117-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 count BEF8D008 3/31/2020
13668-117-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 count BEF8D020 4/30/2020
13668-117-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 count BEF8D021 4/30/2020
13668-117-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 count BEF8D022 4/30/2020
13668-118-30 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 30 count BEF6D038 4/30/2020
13668-118-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count BEF6D030 4/30/2020
13668-118-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count BEF6D031 4/30/2020
13668-118-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count BEF6D047 7/31/2020
13668-118-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90count BEF6D048 7/31/2020
13668-118-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count BEF6D049 7/31/2020
13668-118-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count BEF6D050 7/31/2020
13668-118-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count BEF6D051 7/31/2020
13668-118-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count BEF6D082 10/31/2020
13668-118-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count BEF6D083 10/31/2020
13668-118-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count BEF6D084 10/31/2020
13668-118-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count BEF6D085 10/31/2020
13668-118-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count BEF6D086 10/31/2020
13668-118-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count BEF6D087 10/31/2020
13668-118-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count 4P04E003 1/31/2021
13668-118-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count 4P04E004 1/31/2021
13668-118-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count 4P04E005 1/31/2021
13668-118-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count 4P04E006 1/31/2021
13668-118-10 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 1000 count 4P04E007 1/31/2021
13668-118-10 Losartan Potassium/Hydrochlorothiazide Tablets, USP 100mg/25mg, 1000 count 4P04E008 1/31/2021
13668-118-10 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 1000 count 4P04E009 1/31/2021
13668-118-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count BEF6D051 7/31/2020
13668-118-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count BEF6D082 10/31/2020
13668-118-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count BEF6D083 10/31/2020
13668-118-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count BEF6D084 10/31/2020
13668-118-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count BEF6D085 10/31/2020
13668-118-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count BEF6D086 10/31/2020
13668-118-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count BEF6D087 10/31/2020
13668-118-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count 4P04E003 1/31/2021
13668-118-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count 4P04E004 1/31/2021
13668-118-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count 4P04E005 1/31/2021
13668-118-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count 4P04E006 1/31/2021
13668-118-10 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 1000 count 4P04E007 1/31/2021
13668-118-10 Losartan Potassium/Hydrochlorothiazide Tablets, USP 100mg/25mg, 1000 count 4P04E008 1/31/2021
13668-118-10 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 1000 count 4P04E009 1/31/2021
13668-113-90 Losartan Potassium Tablets, USP 25mg, 90 count BDK1C003 7/31/2019
13668-113-10 Losartan Potassium Tablets, USP 25mg, 1000 count BDK1C002 7/31/2019
13668-113-10 Losartan Potassium Tablets, USP 25mg, 1000 count 4DU1D004 12/31/2019
13668-113-10 Losartan Potassium Tablets, USP 25mg, 1000 count 4DU1D005 12/31/2019
13668-113-10 Losartan Potassium Tablets, USP 25mg, 1000 count 4DU1D006 12/31/2019
13668-409-90 Losartan Potassium Tablets, USP 50mg, 90 count 4DU2D005 12/31/2019
13668-409-90 Losartan Potassium Tablets, USP 50mg, 90 count 4DU2D006 12/31/2019
13668-409-90 Losartan Potassium Tablets, USP 50mg, 90 count 4DU2D026 3/31/2020
13668-409-90 Losartan Potassium Tablets, USP 50mg, 90 count 4DU2D027 3/31/2020
13668-409-90 Losartan Potassium Tablets, USP 50mg, 90 count 4DU2D029 3/31/2020
13668-409-90 Losartan Potassium Tablets, USP 50mg,90 count 4DU2E007 12/31/2020
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2D040 8/31/2020
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2D041 8/31/2020
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2D042 8/31/2020
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2D017 2/29/2020
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2D025 3/31/2020
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2D028 3/31/2020
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2D045 8/31/2020
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2D046 8/31/2020
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2D047 8/31/2020
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2D048 8/31/2020
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2E042 2/28/2021
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2E044 2/28/2021
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count BDK2E001 12/31/2020
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count BDK2E012 8/31/2021
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count BDK2E013 8/31/2021
13668-115-90 Losartan Potassium Tablets, USP 100mg, 90 count 4DU3E016 1/31/2021
13668-115-10 Losartan Potassium Tablets, USP 100mg, 1000 count 4DU3E017 1/31/2021
13668-115-10 Losartan Potassium Tablets, USP 100mg, 1000 count 4DU3E019 2/28/2021
13668-115-10 Losartan Potassium Tablets, USP 100mg, 1000 count 4DU3C012 7/31/2019
13668-115-10 Losartan Potassium Tablets, USP 100mg, 1000 count 4DU3C015 8/31/2019
13668-115-10 Losartan Potassium Tablets, USP 100mg, 1000 count 4DU3C016 8/31/2019
13668-115-10 Losartan Potassium Tablets, USP 100mg, 1000 count 4DU3C017 8/31/2019
13668-115-10 Losartan Potassium Tablets, USP 100mg, 1000 count 4DU3C031 9/30/2019
13668-115-10 Losartan Potassium Tablets, USP 100mg, 1000 count 4DU3D007 1/31/2020
13668-115-10 Losartan Potassium Tablets, USP 100mg, 1000 count 4DU3D008 1/31/2020
13668-116-30 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 30 count BP02D005 12/31/2019
13668-116-30 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 30 count BP02C051 10/31/2019
13668-116-30 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 30 count BEF7D047 11/30/2020
13668-116-90 Losartan Potassium /Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 count BP02D006 12/31/2019
13668-116-90 Losartan Potassium /Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 count BP02D007 12/31/2019
13668-116-90 Losartan Potassium /Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 count BP02D012 1/31/2020
13668-116-90 Losartan Potassium /Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 count BEF7D003 3/31/2020
13668-116-90 Losartan Potassium /Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 count BP02C050 10/31/2019
13668-116-90 Losartan Potassium /Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 count BEF7D026 8/31/2020
13668-116-90 Losartan Potassium /Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 count BEF7D027 8/31/2020
13668-116-90 Losartan Potassium /Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 count BEF7D028 8/31/2020
13668-116-90 Losartan Potassium /Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 count BEF7D045 11/30/2020
13668-116-90 Losartan Potassium /Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 count BEF7D046 11/30/2020
13668-116-90 Losartan Potassium /Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 count BEF7E005 1/31/2021
13668-116-10 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 1000 count BEF7D005 3/31/2020
13668-116-10 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 1000 count BEF7D029 8/31/2020
13668-116-10 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 1000 count BEF7D030 8/31/2020
13668-116-10 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 1000 count BEF7D048 11/30/2020
13668-116-10 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 1000 count BEF7E001 12/31/2020
13668-116-10 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 1000 count BEF7E002 12/31/2020
13668-116-10 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 1000 count BEF7E003 12/31/2020
13668-116-10 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 1000 count BEF7E004 12/31/2020
13668-116-10 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 1000 count BP02C051 10/31/2019
13668-116-10 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 1000 count BP02C052 10/31/2019
13668-117-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 count BEF8D060 11/30/2020
13668-117-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 count BEF8D061 11/30/2020
13668-117-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 count BEF8D062 11/30/2020
13668-117-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 count BEF8D063 11/30/2020
13668-117-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 count BX35D024 1/31/2020
13668-117-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 count BEF8D064 11/30/2020
13668-117-10 Losartan Potassium /Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 1000 count BEF8D059 11/30/2020
13668-117-10 Losartan Potassium /Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 1000 count BEF8E004 1/31/2021
13668-117-10 Losartan Potassium /Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 1000 count BEF8E005 1/31/2021
13668-118-30 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 30 count BEF6D054 8/31/2020
13668-118-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count BEF6D100 11/30/2020
13668-118-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count BEF6D101 11/30/2020
13668-118-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count BEF6D102 11/30/2020
13668-118-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count BEF6E001 12/31/2020
13668-118-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count BEF6E002 12/31/2020
13668-118-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count BEF6E003 12/31/2020
13668-118-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count BEF6E004 12/31/2020
13668-118-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count BEF6E008 12/31/2020
13668-118-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count BEF6E009 12/31/2020
13668-118-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count BEF6E010 12/31/2020
13668-118-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count BEF6E011 12/31/2020
13668-118-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count BEF6E012 12/31/2020
13668-118-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count BP04D012 12/31/2019
13668-118-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count BP04D013 12/31/2019
13668-118-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count BP04C092 10/31/2019
13668-118-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count BEF6D012 3/31/2020
13668-118-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count BEF6D013 3/31/2020
13668-118-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count BEF6D060 9/30/2020
13668-118-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count BEF6D061 9/30/2020
13668-118-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count BEF6D063 9/30/2020
13668-118-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count BEF6D076 10/31/2020
13668-118-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count BEF6D077 10/31/2020
13668-118-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count BEF6D078 10/31/2020
13668-118-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count BEF6D079 10/31/2020
13668-118-10 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 1000 count BP04C094 10/31/2019
13668-118-10 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 1000 count BEF6D096 11/30/2020
13668-118-10 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 1000 count BEF6D097 11/30/2020
13668-118-10 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 1000 count BEF6D098 11/30/2020
13668-118-10 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 1000 count BEF6D099 11/30/2020
13668-118-10 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 1000 count BEF6E005 12/31/2020
13668-118-10 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 1000 count BEF6E006 12/31/2020
13668-118-10 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 1000 count BP04D016 2/29/2020
13668-118-10 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 1000 count BP04D017 2/29/2020
13668-118-10 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 1000 count BP04D018 2/29/2020

 

Torrent Pharmaceuticals Limited is expanding its recall for Losartan Potassium Tablets USP and Losartan Potassium/hydrochlorothiazide tablets, USP, to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited.

Losartan potassium tablets, USP and Losartan potassium/ hydrochlorothiazide tablets, USP were distributed nationwide to Torrent’s wholesale distributor, repackager and retail customers. Torrent Pharmaceuticals Limited is notifying its distributors and customers by phone and in writing to immediately discontinue distribution of the specific lots being recalled and to notify their sub-accounts. Torrent is arranging for return of all recalled products to Qualanex. Instructions for returning recalled products are given in the recall letter.

Consumers with medical questions regarding this recall or to report an adverse event can contact Torrent Pharmaceuticals Limited at:

  • 1-800-912-9561 (live calls received 8:00 am – 5:00 pm Eastern Time, voicemail available 24 hours/day, 7 days/week).

  • Medinfo.Torrent@apcerls.com

Consumers should also contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Any general questions regarding the return of this product should be directed to Qualanex at 1- 888-280-2040 (live calls received 8 am - 9:00 pm Eastern Time).

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Complete and submit the report Online: www.fda.gov/medwatch/report.htm

Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm

Call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Link to Original Recall

Link to 1st Expansion Recall

Link to 2nd Expansion Recall

Link to 3rd Expansion Recall

###

 

 

Topics: Drug Recall
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10 min read

Legacy Pharmaceutical - Voluntary Recall - Losartan Potassium Tablets 25mg, 50mg, And 100mg

By Orville Caval on Apr 3, 2019 8:16:15 AM

When a company announces a recall, market withdrawal, or safety alert, the MKC posts the company's announcement as a public service. MKC does not endorse either the product or the company.
Topics: Drug Recall
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2 min read

Apple Heart Study: Assessment of Wristwatch-Based Photo-Plethysmography to Identify Cardiac Arrhythmias

By Orville Caval on Apr 2, 2019 11:49:00 AM

Apple Heart Study

This research study assessed whether the Apple Heart Study App can effectively use data collected on the Apple Watch to detect irregular heart rhythms, along with those from potentially serious heart conditions such as atrial fibrillation. 419,093 people participated in the study.

Topics: Heart Health
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2 min read

Voluntary Recall - Losartan Potassium Tablets 50mg

By Orville Caval on Mar 18, 2019 8:03:04 AM

When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.
Please call your local pharmacy to find out if your prescription is affected by this recall.

Legacy Pharmaceutical Packaging, LLC is recalling 3 repackaged lots of Losartan Tablets USP 50mg to the consumer level. This recall was prompted due to Torrent Pharmaceuticals LTD issuing a Voluntary Nationwide Recall of Losartan Tablets, USP, due to the detection of trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) a possible process impurity or contaminant in an active pharmaceutical ingredient, manufactured by Hetero Labs Limited, (API manufacturer).

NMBA is a potential human carcinogen. To date, Legacy has not received any reports of adverse events related to this recall.

Losartan Potassium USP is a prescription medication used to treat high blood pressure and congestive heart failure and is packaged in 30ct bottles. The identifying NDC number associated with Legacy’s product is as follows:

Losartan Potassium, USP, 50mg  NDC 68645-494-54

The affected Losartan Potassium includes 3 repackaged lots numbers which are listed below:

LEGACY NDC# Name and Strength Count Legacy Lot # Expiry
68645-494-54 Losartan Potassium Tablets USP 50 mg 30 180190 10/2020
68645-494-54 Losartan Potassium Tablets USP 50 mg 30 180191 10/2020
68645-494-54 Losartan Potassium Tablets USP 50 mg 30 181597 02/2021

The product can be identified by checking the product name and repackaged lot number on the bottle containing these products.

Losartan Potassium was distributed by pharmacies nationwide. Legacy Pharmaceutical Packaging LLC is notifying its distributors and customers in writing and is arranging/assisting for return of all recalled products to Inmar Pharmaceutical Services. Instructions for returning recalled products are provided in the recall letter.

Consumers with questions regarding this recall can contact Inmar at 1-877-538-8443, Monday – Friday, 9am – 5pm EST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Topics: Drug Recall
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6 min read

Voluntary Recall - Losartan Potassium Tablets 25mg, 50mg, And 100mg

By Orville Caval on Mar 18, 2019 7:58:35 AM

When a company announces a recall, market withdrawal, or safety alert, Memorial Katy Cardiology Associates posts the company's announcement as a public service. Memorial Katy Cardiology Associates does not endorse either the product or the company.

Topics: Drug Recall
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2 min read

Voluntary Recall - Valsartan Tablets

By Orville Caval on Mar 7, 2019 1:05:55 PM

American Health Packaging is voluntarily recalling one lot of Valsartan Tablets, USP, 160 mg to the consumer level due to the detection of trace amounts of an unexpected impurity found in the finished drug product. The impurity detected in the finished drug product is N-Nitrosodiethylamine (NDEA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC) classification. This recall is being initiated in response to the recall by the manufacturer (Aurobindo Pharma USA, Inc.), which included the affected lot that was repackaged by American Health Packaging.

Valsartan Tablets USP are indicated to control high blood pressure and for the treatment of heart failure. Patients who prescribed Valsartan Tablets USP should continue taking their medication, as the risk of harm to the patient’s health may be higher if the treatment is stopped immediately without any alternative treatment. Patients should contact their pharmacist or physician who can advise them about an alternative treatment prior to returning their medication.

Product was distributed Nationwide to Wholesalers for use in hospital settings. No reports of injury or adverse events to date.

Product Description AHP Lot No. Expiration Date
Valsartan Tablets USP 160 mg, 100 count Unit Dose Blisters
Carton NDC#: 60687-139-01
(Individual Dose NDC: 60687-139-11)
179791 3/31/2020
Topics: Drug Recall
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13 min read

Voluntary Recall - Losartan Potassium Tablets USP and Losartan Potassium/hydrochlorothiazide Tablets USP

By Orville Caval on Mar 4, 2019 9:13:44 AM

When a company announces a recall, market withdrawal, or safety alert, Memorial Katy Cardiology Associates posts the company's announcement as a public service. Memorial Katy Cardiology Associates does not endorse either the product or the company.

Torrent Pharmaceuticals Limited is voluntarily recalling 60 lots of Losartan potassium tablets USP and 54 lots of Losartan potassium/ hydrochlorothiazide tablets, USP, to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited.

The impurity detected in the API is N-Methylnitrosobutyric acid (NMBA). Torrent is only recalling lots of losartan-containing products that contain N-Methylnitrosobutyric acid (NMBA) above the acceptable daily intake levels released by the FDA.

To date, Torrent Pharmaceuticals Limited has not received any reports of adverse events related to this recall.

Losartan is used to treat hypertension, hypertensive patients with Left Ventricular Hypertrophy and for the treatment of nephropathy in Type 2 diabetic patients. Losartan potassium and hydrochlorothiazide tablets, USP is used to treat hypertension and hypertensive patients with Left Ventricular Hypertrophy.

Patients who are taking Losartan Potassium Tablets, USP and Losartan Potassium/ Hydrochlorothiazide Tablets, USP should continue taking their medication, as the risk of harm to the patient’s health may be higher if the treatment is stopped immediately without any alternative treatment. Patients should contact their pharmacist or physician who can advise them about an alternative treatment prior to returning their medication.

The products subject to recall are listed below. The product can be identified by checking the product name, manufacturer details and batch or lot number on the bottle containing these products.

Losartan Potassium Tablet and Losartan Potassium/ Hydrochlorothiazide Tablet Lots

Topics: Drug Recall
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6 min read

Voluntary Recall - Valsartan and Amlodipine and Valsartan tablets

By Orville Caval on Mar 4, 2019 9:00:05 AM

When a company announces a recall, market withdrawal, or safety alert, Memorial Katy Cardiology Associates posts the company's announcement as a public service. Memorial Katy Cardiology Associates does not endorse either the product or the company.

 

AurobindoPharma USA, Inc. is conducting a voluntary recall expansion of 38 lots of Valsartan and Amlodipine and Valsartan tablets to the consumer level due to the detection of trace amounts of an unexpected impurity found in the finished drug producAurobindoPharma USA, Inc. is conducting a voluntary recall expansion of 38 lots of Valsartan and Amlodipine and Valsartan tablets to the consumer level due to the detection of trace amounts of an unexpected impurity found in the finished drug product. This recall is an expansion of the recall initiated 12/31/18 The impurity detected in the finished drug product is N-nitrosodiethylamine (NDEA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC) classification. The expansion relates to lots distributed under the labels for AurobindoPharma USA, Inc. and Acetris Health, LLC. To date, AurobindoPharma USA, Inc. has not received any reports of adverse events related to this recall.

Amlodipine Valsartan Tablets USP and Valsartan Tablets USP are indicated to control high blood pressure and for the treatment of heart failure. Patients who prescribed Amlodipine Valsartan Tablets USP and Valsartan Tablets USP should continue taking their medication, as the risk of harm to the patient’s health may be higher if the treatment is stopped immediately without any alternative treatment. Patients should contact their pharmacist or physician who can advise them about an alternative treatment prior to returning their medication.

The products subject to recall are listed below and packaged in bottles. The product can be identified by checking the product name, manufacturer details and batch or lot number on the bottle containing these products.

NDC Name and strength Count Lot number Expiry

ACETRIS LOTS

52343-122-30 Valsartan Tablets USP 40mg 30 470170038A 19-Oct
52343-122-30 Valsartan Tablets USP 40mg 30 470180010A 20-Feb
52343-122-30 Valsartan Tablets USP 40mg 30 470180012A 20-Mar
52343-123-90 Valsartan Tablets USP 80mg 90 471170019A 19-Oct
52343-123-90 Valsartan Tablets USP 80mg 90 471180006A 20-Mar
52343-123-90 Valsartan Tablets USP 80mg 90 471180007A 20-Mar
52343-123-90 Valsartan Tablets USP 80mg 90 471180016A 20-May
52343-124-90 Valsartan Tablets USP 160mg 90 472180005B 20-Feb
52343-124-90 Valsartan Tablets USP 160mg 90 472180011A 20-Apr
52343-124-90 Valsartan Tablets USP 160mg 90 472180012A 20-Apr
52343-125-90 Valsartan Tablets USP 320mg 90 473180007A 20-Mar
52343-125-90 Valsartan Tablets USP 320mg 90 473180008A 20-Mar
52343-125-90 Valsartan Tablets USP 320mg 90 473180011A 20-Apr
52343-125-90 Valsartan Tablets, USP 320mg 90 473180020B1 20-Jul

AUROBINDO LOTS

65862-570-30 Valsartan Tablets USP 40mg 30 470180008A 20-Feb
65862-570-30 Valsartan Tablets USP 40mg 30 470180014A 20-Mar
65862-570-30 Valsartan Tablets USP 40mg 30 470180016A 20-Mar
65862-571-90 Valsartan Tablets USP 80mg 90 471170015A 19-Sep
65862-571-90    Valsartan Tablets USP 80mg 90 471180004A 20-Feb
65862-571-90    Valsartan Tablets USP 80mg 90 471180005A 20-Feb
65862-572-90    Valsartan Tablets USP 160mg 90 472180001A 20-Jan
65862-572-90    Valsartan Tablets USP 160mg 90 472180002A 20-Jan
65862-572-90    Valsartan Tablets USP 160mg 90 472180003A 20-Jan
65862-572-90    Valsartan Tablets USP 160mg 90 472180004A 20-Jan
65862-572-90    Valsartan Tablets USP 160mg 90 472180007A 20-Mar
65862-572-90    Valsartan Tablets USP 160mg 90 472180008A 20-Mar
65862-572-90    Valsartan Tablets USP 160mg 90 472180009A 20-Mar
65862-572-90    Valsartan Tablets USP 160mg 90 472180010A 20-Mar
65862-572-90    Valsartan Tablets USP 160mg 90 472180013A 20-Apr
65862-572-90    Valsartan Tablets USP 160mg 90 472180014A 20-Apr
65862-573-90    Valsartan Tablets USP 320mg 90 473180004A 20-Feb
65862-573-90    Valsartan Tablets USP 320mg 90 473180005A 20-Feb
65862-573-90    Valsartan Tablets USP 320mg 90 473180006A 20-Mar
65862-573-90    Valsartan Tablets USP 320mg 90 473180017A 20-May
65862-739-30    Amlodipine and Valsartan Tablets USP10mg/160mg 30 VFSA17007-A 19-Oct
65862-570-30 Valsartan Tablets, USP 40mg 30 470180032A 20-May
65862-573-90 Valsartan Tablets, USP 320mg 90 473170019A 19-Oct
65862-573-90 Valsartan Tablets, USP 320mg 90 473180016A 20-May


Amlodipine Valsartan Tablets USP and Valsartan Tablets USP were distributed nationwide to AurobindoPharma USA, Inc. and Aceteris Health LLC wholesale, distributor, repackager and retail customers. AurobindoPharma USA, Inc. is notifying its distributors and customers by phone and in writing to immediately discontinue distribution of the specific lots being recalled and to notify their sub-accounts. AurobindoPharma USA, Inc. is arranging for return of all recalled products to Inmar. Instructions for returning recalled products are given in the recall letter.

Consumers with medical questions regarding this recall or to report an adverse event can contact AurobindoPharma USA, Inc. at:

1-866-850-2876 Option 2
pvg@aurobindousa.com
Consumers should also contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Any general questions regarding the return of this product please contact Inmar\CLS-Medturn at 1-877-208-2407 or email aurobindorecalls@inmar.com (live calls received 9 am -5:00 pm Eastern Time).

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Complete and submit the report Online: www.fda.gov/medwatch/report.htm
Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm Call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

 

 

 

 

Topics: Drug Recall
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16 min read

Voluntary Recall - Losartan Tablets USP 25 mg, 50 mg, and 100 mg

By Orville Caval on Mar 4, 2019 8:50:37 AM

When a company announces a recall, market withdrawal, or safety alert, Memorial Katy Cardiology Associates posts the company's announcement as a public service. Memorial Katy Cardiology Associates does not endorse either the product or the company.

Camber Pharmaceuticals, Inc. is recalling 87 lots of Losartan Tablets USP 25 mg, 50 mg, and 100 mg to consumer level. This recall was prompted due to the detection of trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) a possible process impurity or contaminant in an active pharmaceutical ingredient, manufactured by Hetero Labs Limited, Unit – I (API manufacturer).

NMBA is a potential human carcinogen. To date, Camber has not received any reports of adverse events related to this recall.

Losartan Potassium, USP, is a prescription medication used to treat high blood pressure and congestive heart failure and is packaged in 30ct, 90ct, 500ct, 1000ct bottles. The identifying NDC #s associated with Camber’s product as are follows: Losartan 25 mg 31722-700-90, 31722-700-05, 31722-700-10; Losartan 50 mg 31722-701-30, 31722-701-90, 31722-70-10; and Losartan 100 mg 31722-702-30, 31722-702-90, and 31722-702-10.

The affected Losartan includes 87 lot numbers which are listed below:

NDC Name and Strength Count Lot# Expiry
31722-700-90 Losartan Potassium Tablets USP 25 mg 90 LOP17026B Sep-19
31722-700-90 Losartan Potassium Tablets USP 25 mg 90 LOP17050 Sep-19
31722-700-90 Losartan Potassium Tablets USP 25 mg 90 LOP17051 Sep-19
31722-700-90 Losartan Potassium Tablets USP 25 mg 90 LOP17052 Sep-19
31722-700-90 Losartan Potassium Tablets USP 25 mg 90 LOP17053 Sep-19
31722-700-90 Losartan Potassium Tablets USP 25 mg 90 LOP17061 Oct-19
31722-700-90 Losartan Potassium Tablets USP 25 mg 90 LOP18035 Dec-19
31722-700-90 Losartan Potassium Tablets USP 25 mg 90 LOP18036 Dec-19
31722-700-05 Losartan Potassium Tablets USP 25 mg 500 LOP17026 Sep-19
31722-700-10 Losartan Potassium Tablets USP 25 mg 1000 LOP17006 May-19
31722-700-10 Losartan Potassium Tablets USP 25 mg 1000 LOP17025 Sep-19
31722-700-10 Losartan Potassium Tablets USP 25 mg 1000 LOP17068 Oct-19
31722-700-10 Losartan Potassium Tablets USP 25 mg 1000 LOP18037 Dec-19
31722-700-10 Losartan Potassium Tablets USP 25 mg 1000 LOP18038 Dec-19
31722-700-10 Losartan Potassium Tablets USP 25 mg 1000 LOP18039 Dec-19
31722-700-10 Losartan Potassium Tablets USP 25 mg 1000 LOP18057 Jan-20
31722-701-30 Losartan Potassium Tablets USP 50 mg 30 LOP17028C Sep-19
31722-701-30 Losartan Potassium Tablets USP 50 mg 30 LOP17064A Nov-19
31722-701-90 Losartan Potassium Tablets USP 50 mg 90 LOP17027 Sep-19
31722-701-90 Losartan Potassium Tablets USP 50 mg 90 LOP17063 Nov-19
31722-701-90 Losartan Potassium Tablets USP 50 mg 90 LOP17093 Nov-19
31722-701-90 Losartan Potassium Tablets USP 50 mg 90 LOP17094 Dec-19
31722-701-90 Losartan Potassium Tablets USP 50 mg 90 LOP17095 Dec-19
31722-701-90 Losartan Potassium Tablets USP 50 mg 90 LOP17097A Dec-19
31722-701-90 Losartan Potassium Tablets USP 50 mg 90 LOP17105 Dec-19
31722-701-90 Losartan Potassium Tablets USP 50 mg 90 LOP17107 Dec-19
31722-701-10 Losartan Potassium Tablets USP 50 mg 1000 LOP17004 Dec-19
31722-701-10 Losartan Potassium Tablets USP 50 mg 1000 LOP17028B Sep-19
31722-701-10 Losartan Potassium Tablets USP 50 mg 1000 LOP17048 Oct-19
31722-701-10 Losartan Potassium Tablets USP 50 mg 1000 LOP17049 Oct-19
31722-701-10 Losartan Potassium Tablets USP 50 mg 1000 LOP17056 Nov-19
31722-701-10 Losartan Potassium Tablets USP 50 mg 1000 LOP17073 Nov-19
31722-701-10 Losartan Potassium Tablets USP 50 mg 1000 LOP17074 Nov-19
31722-701-10 Losartan Potassium Tablets USP 50 mg 1000 LOP17076 Nov-19
31722-701-10 Losartan Potassium Tablets USP 50 mg 1000 LOP17096 Dec-19
31722-701-10 Losartan Potassium Tablets USP 50 mg 1000 LOP18077A Feb-20
31722-701-10 Losartan Potassium Tablets USP 50 mg 1000 LOP18078 Feb-20
31722-701-10 Losartan Potassium Tablets USP 50 mg 1000 LOP18079 Feb-20
31722-701-10 Losartan Potassium Tablets USP 50 mg 1000 LOP18080 Feb-20
31722-701-10 Losartan Potassium Tablets USP 50 mg 1000 LOP18081 Mar-20
31722-701-10 Losartan Potassium Tablets USP 50 mg 1000 LOP18084 Mar-20
31722-701-10 Losartan Potassium Tablets USP 50 mg 1000 LOP18095 Mar-20
31722-701-10 Losartan Potassium Tablets USP 50 mg 1000 LOP18096 Mar-20
31722-702-30 Losartan Potassium Tablets USP 100 mg 30 LOP17011 Aug-19
31722-702-30 Losartan Potassium Tablets USP 100 mg 30 LOP17087 Nov-19
31722-702-90 Losartan Potassium Tablets USP 100 mg 90 LOP17012 Aug-19
31722-702-90 Losartan Potassium Tablets USP 100 mg 90 LOP17013 Aug-19
31722-702-90 Losartan Potassium Tablets USP 100 mg 90 LOP17042 Oct-19
31722-702-90 Losartan Potassium Tablets USP 100 mg 90 LOP17043 Oct-19
31722-702-90 Losartan Potassium Tablets USP 100 mg 90 LOP17044 Nov-19
31722-702-90 Losartan Potassium Tablets USP 100 mg 90 LOP17045 Nov-19
31722-702-90 Losartan Potassium Tablets USP 100 mg 90 LOP18024 Dec-19
31722-702-90 Losartan Potassium Tablets USP 100 mg 90 LOP18025 Dec-19
31722-702-90 Losartan Potassium Tablets USP 100 mg 90 LOP18026 Dec-19
31722-702-90 Losartan Potassium Tablets USP 100 mg 90 LOP18027 Dec-19
31722-702-90 Losartan Potassium Tablets USP 100 mg 90 LOP18028 Dec-19
31722-702-90 Losartan Potassium Tablets USP 100 mg 90 LOP18029 Dec-19
31722-702-90 Losartan Potassium Tablets USP 100 mg 90 LOP18030 Dec-19
31722-702-10 Losartan Potassium Tablets USP 100 mg 1000 LOP17005 May-19
31722-702-10 Losartan Potassium Tablets USP 100 mg 1000 LOP17014 Aug-19
31722-702-10 Losartan Potassium Tablets USP 100 mg 1000 LOP17016 Sep-19
31722-702-10 Losartan Potassium Tablets USP 100 mg 1000 LOP17023 Sep-19
31722-702-10 Losartan Potassium Tablets USP 100 mg 1000 LOP17083 Oct-19
31722-702-10 Losartan Potassium Tablets USP 100 mg 1000 LOP17084 Nov-19
31722-702-10 Losartan Potassium Tablets USP 100 mg 1000 LOP17085 Nov-19
31722-702-10 Losartan Potassium Tablets USP 100 mg 1000 LOP17086 Nov-19
31722-702-10 Losartan Potassium Tablets USP 100 mg 1000 LOP18021 Dec-19
31722-702-10 Losartan Potassium Tablets USP 100 mg 1000 LOP18022 Dec-19
31722-702-10 Losartan Potassium Tablets USP 100 mg 1000 LOP18023 Dec-19
31722-702-10 Losartan Potassium Tablets USP 100 mg 1000 LOP18031 Dec-19
31722-702-10 Losartan Potassium Tablets USP 100 mg 1000 LOP18032 Dec-19
31722-702-10 Losartan Potassium Tablets USP 100 mg 1000 LOP18033 Dec-19
31722-702-10 Losartan Potassium Tablets USP 100 mg 1000 LOP18050 Dec-19
31722-702-10 Losartan Potassium Tablets USP 100 mg 1000 LOP18051 Dec-19
31722-702-10 Losartan Potassium Tablets USP 100 mg 1000 LOP18109 Mar-20
31722-702-10 Losartan Potassium Tablets USP 100 mg 1000 LOP18111 Mar-20
31722-702-10 Losartan Potassium Tablets USP 100 mg 1000 LOP18122 Jun-20
31722-702-10 Losartan Potassium Tablets USP 100 mg 1000 LOP18123 Jun-20
31722-702-10 Losartan Potassium Tablets USP 100 mg 1000 LOP18124 Jun-20
31722-702-10 Losartan Potassium Tablets USP 100 mg 1000 LOP18125 Jun-20
31722-702-10 Losartan Potassium Tablets USP 100 mg 1000 LOP18126 Jun-20
31722-702-10 Losartan Potassium Tablets USP 100 mg 1000 LOP18127 Jun-20
31722-702-10 Losartan Potassium Tablets USP 100 mg 1000 LOP18128 Jun-20
31722-702-10 Losartan Potassium Tablets USP 100 mg 1000 LOP18129 Jun-20
31722-702-10 Losartan Potassium Tablets USP 100 mg 1000 LOP18130 Jun-20
31722-702-10 Losartan Potassium Tablets USP 100 mg 1000 LOP18131C Jun-20
31722-702-10 Losartan Potassium Tablets USP 100 mg 1000 LOP18133 Jun-20

Losartan Potassium Tablets were distributed Nationwide to Wholesalers, Distributors, Retail Pharmacies, and Mail Order Pharmacies.

Stericycle is notifying Camber’s distributors and other customers by recall letter and arranging for return of recalled product of Losartan Potassium Tablets.

Consumers should contact their doctor for further guidance and potential change of treatment before they stop taking the product. Pharmacies and healthcare facilities that have the product being recalled should stop using and dispensing the product immediately.

Consumers with questions regarding this recall can contact Camber Pharmaceuticals’ Med Line at 1-866-495-1995 Monday – Friday, 9am – 5pm EST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch

Adverse reactions or quality problems associated with the use of this product may be reported to FDA's MedWatch Adverse Event Reporting program either by phone, on line, by regular mail or by fax.

Complete and submit the report Online: www.fda.gov/medwatch/report.htm
Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.
This recall is being conducted with the knowledge of the U.S. Food and Drug administration.

 

Topics: Drug Recall
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2 min read

Voluntary Nationwide Recall of One Lot (BLM 715A) Losartan Potassium/Hydrochlorothiazide Tablets 100mg/25mg

By Orville Caval on Feb 25, 2019 11:00:56 AM

When a company announces a recall, market withdrawal, or safety alert, Memorial Katy Cardiology Associates posts the company's announcement as a public service. Memorial Katy Cardiology Associates does not endorse either the product or the company.

 

Macleods Pharmaceuticals Limited is voluntarily recalling one lot of Losartan Potassium/Hydrochlorothiazide combination tablets 100mg/25mg to the consumer level due to the detection of trace amounts of an unexpected impurity (NDEA) found in finished product manufactured with active pharmaceutical ingredient made by Hetero Labs Limited.

Risk Statement: The impurity detected is N-nitrosodiethylamine (NDEA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC) classification. Macleods is recalling one lot of Losartan Potassium/Hydrochlorothiazide combination tablets 100mg/25mg that contains NDEA above the interim acceptable daily intake levels released by the FDA.

To date, Macleods Pharmaceuticals Limited has not received any reports of adverse events related to this recall.

Losartan Potassium/Hydrochlorothiazide combination tablets are indicated to treat hypertension and hypertensive patients with Left Ventricular Hypertrophy. Patients who are on Losartan Potassium/Hydrochlorothiazide combination tablets, USP should continue taking their medication, as the risk of harm to the patient's health may be higher if the treatment is stopped immediately without any alternative treatment.

The product subject to recall is listed below and packaged in bottles. The product can be identified by checking the product name, manufacturer details and batch or lot number on the bottle containing these products.

NDC Manufacturer Product Description Lot/Batch Expiration Date
33342-0052-10 Macleods Pharmaceuticals Limited Losartan Potassium/ Hydrochlorothiazide combination tablets 100mg/25mg, 90 count bottles BLM715A Jul -2019
The representation of the Label is as provided below

Losartan Potassium/Hydrochlorothiazide combination tablets 100mg/25mg were distributed nationwide to Macleods wholesale distributor and retail customers. Macleods Pharmaceuticals Limited is notifying its distributors and customers by phone and/or in writing to immediately discontinue distribution of the specific lot being recalled and to notify their sub-accounts. Macleods is arranging for return of all recalled products to Qualanex. Instructions for returning recalled products are given in the recall letter.

If you have any general questions regarding the return of this product please contact Qualanex via email at recall@qualanex.com or call 888-280-2042 (7:00 am to 4:00 pm CST Monday to Friday).

Consumers should also contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems associated with the use of this product may be reported to FDA's MedWatch Adverse Event Reporting program by phone, on line, either by regular mail or by fax.

  1. Complete and submit the report Online: www.fda.gov/medwatch/report.htm
  2. Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.
    This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Topics: Drug Recall
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3 min read

Heart Disease and Stroke Statistics, 2019 Update

By Orville Caval on Feb 20, 2019 10:10:07 AM

This just in, the Heart Disease and Stroke Statistics 2019 update from the American Heart Association reveals that:

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3 min read

High blood pressure the leading factor contributing to stroke in young adults

By Orville Caval on Feb 11, 2019 12:00:00 AM

Strokes do not discriminate by age.

They hit once the factors are right – and these factors may be found as often in younger adults who have strokes as in older populations, according to a new study.

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5 min read

Voluntary Nationwide Recall for Losartan Potassium Tablets and Losartan Potassium and Hydrochlorothiazide Tablets

By Orville Caval on Feb 6, 2019 12:00:00 AM

When a company announces a recall, market withdrawal, or safety alert, Memorial Katy Cardiology Associates posts the company's announcement as a public service. Memorial Katy Cardiology Associates does not endorse either the product or the company.

Please call your local pharmacy to find out if your prescription is affected by this recall.

Topics: Drug Recall
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1 min read

February is for lovers.

By Orville Caval on Feb 4, 2019 3:54:41 PM

February is for lovers. February also reminds us to take care of our heart; it is American Heart Month.

The annual celebration started in 1963 to encourage Americans to join the battle against heart disease. A presidential proclamation pays tribute every year to researchers, physicians, public health professionals and volunteers for their tireless efforts in preventing, treating and researching heart disease, which is the leading cause of death for both men and women within the U.S.

Hospitals and health systems around the country celebrate American Heart Month by consigning to raise awareness in their communities regarding heart disease. Employees wear red and volunteers knit or crochet pint-size red hats for newborns. They hold free screenings and heart health awareness events.

It’s an excellent time to commit to a healthy life style and make small changes that may result in a lifetime of heart health. If you’re not doing so already, become involved in American Heart Month. Get involved and spread the word about strategies for preventing heart disease and living heart healthy lives!

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1 min read

Dr. John Sunew Joins Memorial City and Katy Cardiology

By Neil Schmitz on Jan 29, 2014 3:35:00 PM

Dr. John Sunew recently joined our group of West Houston Cardiogists! He will start seeing patients in all 3 locations as of February 3rd, 2014. Schedule your appointment to see him in any of these 3 locations soon.

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1 min read

Need Health Insurance in Katy or West Houston?

By Neil Schmitz on Sep 30, 2013 7:21:00 PM

Whether you are an individual trying to see one of our Cardiologists in Katy or West Houston, or if you work for a small business that does not provide coverage, you should know that there are now options for you to obtain health insurance courtesy of what many refer to as 'ObamaCare'.

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2 min read

TOP 3 Reasons to Have a Cardiac PET at Katy Cardiology

By Neil Schmitz on Nov 30, 2012 1:11:00 PM

Having palpitations or chest pain while exercising?  Need a Katy Cardiologist to check it out?

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1 min read

Houston Cardiology Patients - Atorvastatin (generic Lipitor) Recall

By Neil Schmitz on Nov 26, 2012 10:33:00 AM

Are you a west houston cardiology patient of ours?  Are you taking generic Lipitor (Atorvastatin)?  

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2 min read

Choosing a Heart Healthy Diet can Save Your Life

By Neil Schmitz on Jun 21, 2012 8:55:00 PM

Many of our Cardiology patients in West Houston constantly ask us about what they can do to improve their condition, and ultimately the best thing any of us can do is to eat a heart healthy diet!

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