Expanded Recall Alert for LosartanElizabeth Nelson
Shortly following a recall of two lots of Losartan potassium tablets USP, Torrent Pharmaceuticals Limited is expanding their recall to include 10 lots of the medication.
Losartan is an angiotensin receptor blocker (ARB) which works by relaxing the blood vessels so that the blood can flow more easily. It is often used to treat high blood pressure and heart problems and prevent stroke and heart attack, as well as to protect the kidneys against damage related to type 2 diabetes. It is generally prescribed to patients with hypertension, left ventricular hypertrophy, or nephropathy.
December’s recall included lot numbers BO31C016 and 4DK3C005. The newly expanded recall also includes:
- 100mg, 1,000-count bottles, lot Nos. 4DK3C004, 4DU3C040, 4DU3E049 and 4DU3E050
- 50mg, 30-count bottles, lot No. 4L67C305
- 50mg, 90-count bottles, lot Nos. 4L67C305 and 4L67C306
- 50mg, 1,000-count bottles, lot No. 4O50C005
- 25mg, 90-count bottles, lot No. 4O49C013
For clarification, the recall notice states, “Torrent is only recalling lots of losartan-containing products that contain N-nitrosodiethylamine (NDEA) above the acceptable daily intake levels released by the FDA.”
See the recall page for more information on the specific product descriptions for the recalled items, including lot and batch numbers and expiration dates.
N-nitrosodiethylamine (NDEA) has been wreaking havoc lately in the world of pharmaceutical drugs. The substance occurs naturally in certain foods, water, air pollution, and industrial processes, but only very small trace amounts of it are safe. According to the International Agency for Research on Cancer, it is considered a probable human carcinogen. Several drug companies have recalled Losartan and Valsartan drugs for NDEA impurities over the last several months.
So far, there have been no reports of illness related to the contaminated Losartan drug. If you believe you are experiencing an adverse reaction to the drug, you should report it to the FDA’s MedWatch Adverse Event Reporting program.
If you are taking this recalled medication, it is NOT advised to go off it until you have arranged for alternative treatment. Contact your doctor or pharmacist to find out how to get a replacement.
Those with questions or concerns about the recall can call Torrent Pharmaceuticals Limited at 800-912-9561 from 8 a.m. to 5 p.m. EST or email MedInfo.Torrent@apcerls.com. Questions about returning the drug can be directed to Qualanex at 1-888-280-2040 from 8 a.m. to 9 p.m. EST.
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