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Recall of hypertension drug bottles from US by Hetero Labs on account of cGMP issues

Hetero Labs is recalling over 15.90 lakh bottles of Valsartan Tablets USP in the strengths of 40 mg, 80 mg, 160 mg and 320 mg from US market due to deviations from good manufacturing norms. The tablets were manufactured by the company for Camber Pharmaceuticals Inc.

Valsartan is used for the treatment of hypertension. The voluntary ongoing nationwide recall is a class II recall. Lots with expiry dates 7/2018 to 6/2020 are being recalled due to current good manufacturing practice (cGMP) deviations: Carcinogen impurity detected in active pharmaceutical ingredient (API) used to manufacture drug product.