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Aurobindo recalls nearly 5 lakh bottles of blood pressure drug in US

Press Trust of India  |  New Delhi 

Drug firm Aurobindo is recalling close to 5 lakh of blood pressure lowering in the US after the American health regulator found certain deviations from Current (CGMP) regulations.

According to the latest Enforcement Report by the the (USFDA), the Hyderabad-based is recalling 1,62,301 of and Valsartan Tablets, 3,12,095 of Valsartan and Hydrochlorothiazide tablets and 20,604 bottles of in the US.

The drug firm is recalling the after FDA lab confirmed presence of an impurity N-nitrosodimethylamine (NDEA) contained in the used to manufacture the product, above the interim acceptable daily intake level of 0.083 parts per million.

The company's US-based arm USA Inc is recalling the lots.

The USFDA has classified it as a recall, which is initiated in a "situation in which use of or exposure to a may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote".

Another is voluntarily recalling 7,215 bottles of for Oral Suspension USP, used to treat a wide variety of bacterial infections, in the US due deviations.

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 recall.

(This story has not been edited by Business Standard staff and is auto-generated from a syndicated feed.)

First Published: Sun, January 27 2019. 12:05 IST