Zydus Cadila recalls over 10,000 bottles of allergy drug in US

Mumbai, 30 May, 2014

Gujarat headquartered Zydus Cadila’s US unit, Zydus Pharmaceuticals USA Inc is voluntarily recalling 10,200 bottles of an allergy-relief drug carrying an expiry date of September 2015 in the United States after another drug for high blood pressure medicine atenolol was found in one of the bottles containing the allergy drug, promethazine hydrochloride, the US Food and Drug Administration said on Friday.

Promethazine hydrochloride is commonly used to treat allergic disorders, nausea, vomiting, difficulty sleeping, as well as for pre-operative sedation. The FDA classified the recall as Class II, which means use of or exposure to the recalled products may cause temporary or medically reversible adverse health consequences.

The FDA has increased its scrutiny of Indian drugmakers after the agency banned exports from manufacturing plants of some top drugmakers, including Ranbaxy and Wockhardt, upon finding quality control lapses. Zydus’s drug recall is the seventh this year by an Indian company, and follows those by other large drugmakers including Wockhardt Ltd, Ranbaxy Laboratories Ltd , Dr. Reddy’s Laboratories Ltd, Lupin Ltd , Sun Pharmaceutical Industries Ltd and Glenmark Pharmaceuticals Ltd.