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Orville Caval


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3 min read

Your Heart Health and Nicotine

By Orville Caval on Oct 11, 2019 10:00:00 AM

Smoking is a leading cause of preventable deaths and disease:

The leading cause of deaths and disease in the United States, as well as the whole world, is smoking. There is no doubt about in the harms and effects of smoking.

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1 min read

Sleeping less than 6 hours may raise risk of cancer, even death

By Orville Caval on Oct 3, 2019 9:00:00 AM

Not getting enough sleep may put some people at risk for much more than being drowsy the next day, a new study says.

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6 min read

Updated: Torrent Pharmaceuticals Limited Expands Voluntary Nationwide Recall of Losartan

By Orville Caval on Sep 20, 2019 12:03:54 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.
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Summary

Company Announcement Date:
FDA Publish Date:
Product Type: Drugs
Reason for Announcement: Due to the Detection of N-Methylnitrosobutyric acid (NMBA)
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 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 while testing the below finished product batches manufactured utilizing active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited using the old Route of Synthesis. The recall is expanded to include an additional 3 lots of Losartan Potassium Tablets USP and 2 lots of Losartan Potassium/Hydrochlorothiazide Tablets, USP.

The impurity detected 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.

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. 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 Product Name, Strength and Package Count Batch Number Expiration Date
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2E009 12/31/2020
13668-115-90 Losartan Potassium Tablets, USP 100mg, 90 count 4DU3E009 12/31/2020
13668-115-10 Losartan Potassium Tablets, USP 100mg, 1000 count 4DU3D018 02/28/2021
13668-116-90 Losartan Potassium / Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 count BEF7D051 11/30/2020
13668-118-90 Losartan Potassium / Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count. 4P04D007 07/31/2020

 

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

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

Link to Original Recall
Link to 1st Expansion Recall
Link to 2nd Expansion Recall
Link to 3rd Expansion Recall
Link to 4th Expansion Recall


Company Contact Information

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

Product Photos

Topics: Drug Recall
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6 min read

You’re So Vein: The Best Ways To Treat & Prevent Varicose and Spider Veins

By Orville Caval on Sep 17, 2019 9:30:00 AM

Carly Simon may have been talking about a different kind of vanity. But, if you’re part of the 50 percent of adults living with a leg vein disorder, MKC Vein & Vascular Center is here with the best way to treat and prevent varicose and spider veins.

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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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Houston Heart Care Blog 

Houston Heart Care Blog covers heart disease, stroke, vascular disease, and related health issues. Not all views expressed in Houston Heart Care Blog stories reflect the official position of Memorial Katy Cardiology Associates.

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