FDA recalls drug after finding trace amounts of a carcinogen

A company called Torrent Pharmaceuticals Limited is recalled several batches of Losartan potassium tablets.

It’s a drug that’s used to treat hypertension and complications from Type 2 diabetes.

On Thursday, the Food and Drug Administration said that trace amounts of a known carcinogen were found in the medication. Additionally, the FDA warned that patients using any of the drugs included in the recall should contact their doctor before stopping the use of Losartan completely.

There are the batches affected:

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 4DU3E018 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

If you have any medical questions, you should 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

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

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