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The US Food and Drug Administration (FDA) has announced that Solco Healthcare LLC voluntarily recalled a batch of irbesartan and seven batches of combined tablets of irbesartan and hydrochlorothiazide (HCTZ).
These tablets are recalled due to the presence of "unacceptable" amounts of N-nitrosodiethylamine (NDEA) in the active pharmaceutical ingredient irbesartan. This carcinogenic ingredient was manufactured by Zhejiang Huahai Pharmaceuticals (ZHP).
The recall only concerns many drugs containing irbesartan for which NDEA was found above the limit of 0.088 parts per million. According to the FDA, the acceptable intake of NDEA is a daily exposure that results in a cancer risk of 1: 100,000 after 70 years of exposure.
The recalled irbesartan products are those sold by the companies: ScieGen Pharmaceuticals, bearing the Westminster Pharmaceuticals label, ScieGen Pharmaceuticals, bearing the symbol GSMS Incorporated, and Prinston Pharmaceutical Inc., from the manufacturer Solco Healthcare LLC. The complete and updated reminder list is available. To date, 45 batches of irbesartan tablets or irbesartan tablets and hydrochlorothiazide have been recalled, with an expiry date as distant as March 2021.
Some batches of irbesartan tablets were recalled in 2018, as early as July. Throughout the summer and fall, additional batches have also been recalled due to impurities in the NDEA.
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