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Updated Drug Recall Alert: Losartan Tablets

1 year, 1 month ago

6277  0
Posted on Apr 21, 2019, 6 p.m.

Torrent Pharmaceuticals Limited has expanded the voluntary Nationwide recall of its Losartan Potassium Tablets, USP and Losartan Potassium/Hydrochlorothiazide Tablets, USP due to consumer level detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient manufactured by Hetero Labs Limited.

Recall has been expanded to include an additional 36 lots of Losartan Potassium Tablets, USP and Losartan Potassium/Hydrochlorothiazide Tablets, USP due to an impurity in the API of NMBA, lots are only being recalled that contain NMBA above the daily intake levels released by the FDA; no adverse events have been reported related to this recall.

Losartan is used to treat hypertension, hypertensive patients with left ventricular hypertrophy, and nephropathy in Type 2 diabetic patients; USP, Losartan potassium, and hydrochlorothiazide tablets are used to treat hypertension and hypertensive patients with left ventricular hypertrophy.

These products were distributed nationwide to wholesale, repackagers, and retail customers which have been notified. Those with any medical questions regarding the recall, or needing to report an adverse event can contact Torrent at 1-800-912-9561.

This is a long list of affected products, links are below to the recalls:

Original recall: https://www.fda.gov/Safety/Recalls/ucm628966.htm

Expanded recall: https://www.fda.gov/Safety/Recalls/ucm629261.htm

Expanded recall: https://www.fda.gov/Safety/Recalls/ucm629693.htm

Expanded recall: https://www.fda.gov/Safety/Recalls/ucm632509.htm

Expanded recall: https://www.fda.gov/Safety/Recalls/ucm636296.htm

General questions regarding return of the product can be directed to Qualanex at 1-888-280-2040.

Anyone taking this medication is advised to contact their physician if they have experienced problems that may be related to taking this product. Patients taking this medication should contact their pharmacist and physician to be advised on alternative treatments before returning any medications. Adverse reactions or quality problems can be reported to the FDA at 1-800-332-1088.




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This article is not intended to provide medical endorsement, advice, diagnosis or treatment.

https://www.fda.gov/Safety/Recalls/ucm636296.htm



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