Zydus Cadila voluntarily recalls allergy drug in the US

FDA calls it Class II recall; 10,200 bottles to be recalled nationwide

Adding to the growing number of drug recalls by Indian drug companies in the US, Ahmedabad-based Cadila Healthcare's US subsidiary has initiated a nation-wide voluntary recall of 10,200 bottles of its allergy-relief drug due to the presence of foreign tablets of another drug (atenolol) in the bottles of a particular lot.

According to the US Food and Drug Administration (USFDA), this is a Class II recall voluntarily initiated by the company. As the cause for recall it notes the presence of foreign tablets of atenolol 25 mg mixed into promethazine 25 mg tablet bottles and mentions the Lot number MN9081. Promethazine hydrochloride tablets (25 mg) are manufactured by Cadila Healthcare Ltd and are distributed by Zydus Pharmaceuticals USA Inc. Each bottle contains 100 tablets. The expiry date of the lot is September 2015.

Promethazine is used to treat allergic disorders, nausea and vomiting, difficulty sleeping, preoperative sedation in surgery or obstetrics. While atenolol is used to treat angina (chest pain) and hypertension (high blood pressure).

Pankaj Patel, chairman and managing director of Cadila Healthcare could not be immediately reached for a comment.

Earlier in June 2013, Zydus Cadila's US subsidiary had voluntarily recalled one lot of warfarin 2 mg tablets as some of the tablets in the lot were found to be oversized. Warfarin is used as a prophylaxis and treatment of venous thrombosis and its extension. Basically, it is a blood thinner that is widely used to prevent blood clots in patients with irregular heartbeats or a history of heart attack.

Other major cases of drug recall by Ahmedabad-based companies  includes that of Claris Lifesciences, which had announced a nationwide recall of all lots of Ciprofloxacin, Metronidazole and Ondansetron from the US voluntarily following a report of its US distributor Sagent Pharmaceuticals and its customer Pfizer that Metronidazole injection USP IV bags were contaminated with fungi. Claris had entered into a supply deal with Pfizer in 2009 to gain access to markets like the US, Europe and Australia. Post the recall, Pfizer and Claris had reviewed the supply agreement in the wake of import alert from its Bavla site and the supply agreement was terminated.

While voluntary recalls of drugs in the US by manufacturers is not uncommon, it assumes significance in the backdrop of the recent increased scrutiny by the FDA on Indian manufacturing sites. Zydus's recall is the seventh this year by an Indian company, after other major drugmakers like Wockhardt, Dr. Reddy's Laboratories, Sun Pharmaceuticals, Ranbaxy Laboratories, Lupin and Glenmark have also recalled their drugs in the US market for various reasons.