FDA Update on Valsartan Recalls
The U.S. Food and Drug Administration is updating health care professionals and patients that Torrent Pharmaceuticals Limited is voluntarily recalling 16 lots of valsartan/amlodipine tablets and valsartan/amlodipine/hydrochlorothiazide (HCTZ) tablets. Not all Torrent valsartan products distributed in the U.S. are being recalled. The FDA recently learned Torrent used affected valsartan active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceuticals. FDA testing confirmed NDMA in some Torrent products.
To date, Torrent has not received any reports of adverse events related to this recall.
FDA has updated the list of valsartan products under recall and the list of valsartan products not under recall to incorporate additional repackagers of Camber’s valsartan products and Torrent’s recall.
NDMA is a known environmental contaminant. For context, it is found in water and foods including meats, dairy products and vegetables. Estimated Range of Daily NDMA Consumption for certain foods (Recommended daily food consumption rates based on Dietary Guidelines for Americans 2015-2020)
- Cured meat - 0.004-0.23 micrograms
- Smoked meat - 0.004-1.02 micrograms
- Grilled meat - 0.006-0.13 micrograms
- Bacon - 0.07-0.09 micrograms
- For example, one pound of bacon may contain 0.304-0.354 micrograms of NDMA
FDA reminds patients taking valsartan from a recalled lot that they should continue taking their current medicine until their doctor or pharmacist provides a replacement or a different treatment option. Not all valsartan products contain NDMA, so pharmacists may be able to provide a refill of valsartan medication not affected by the recall, or doctors may prescribe a different medication that treats the same condition.
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