Drug firm Aurobindo is recalling close to 5 lakh bottles of blood pressure lowering drugs in the US after the American health regulator found certain deviations from Current Good Manufacturing Practice (CGMP) regulations.
According to the latest Enforcement Report by the the US Food and Drug Administration (USFDA), the Hyderabad-based Aurobindo Pharma is recalling 1,62,301 bottles of Amlodipine and Valsartan Tablets, 3,12,095 bottles of Valsartan and Hydrochlorothiazide tablets and 20,604 bottles of Valsartan tablets in the US.
The drug firm is recalling the drugs after FDA lab confirmed presence of an impurity N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product, above the interim acceptable daily intake level of 0.083 parts per million.
The company's US-based arm Aurobindo Pharma USA Inc is recalling the lots.
The USFDA has classified it as a Class-II recall, which is initiated in a "situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote".
According to the USFDA, the company is recalling the bottles as "manufacturing batch record could not be located". The US drug regulator has classified it as a Class-II recall.
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