Houston Heart Care Blog | Memorial Katy Cardiology Associates

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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