New Delhi: Indian drug firm Hetero Labs is recalling over 15.90 lakh bottles of Valsartan Tablets used for treatment of hypertension from the American market due to deviations from the good manufacturing norms, the latest enforcement report of the US health regulator has said.
Hetero Labs is recalling 15,94,092 bottles of Valsartan Tablets USP in the strengths of 40 mg, 80 mg, 160 mg and 320 mg, manufactured by the company for Camber Pharmaceuticals Inc, United States Food and Drug Administration (USFDA) said in its report.
The company is “recalling all lots with expiration dates 7/2018 to 6/2020," it added.
The reason for the recall is current good manufacturing practice (CGMP) deviations: Carcinogen impurity detected in active pharmaceutical ingredient (API) used to manufacture drug product, the health regulator said. The voluntary ongoing nationwide recall is a class II recall, it added.
As per the USFDA, a class II recall 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."