WOCKHARDT RECALLS METOPROLOL SUCCINATE FOR THIRD TIME DUE TO DISSOLUTION FAILURE

New Delhi, September 08, 2014 – Wockhardt is voluntarily recalling two lots of metoprolol succinate extended-release tablets, USP, 200 mg in 100-count and 500-count bottles due to failed dissolution specifications in the US. This is the company’s third recall of the same drug in the past four months. The recall is for 11,661 bottles. Metoprolol is a generic form of AstraZenecas branded drug Toprol.

Reason of the recall was specified as dissolution failures found during testing of control samples at the four hour time point. A dissolution test is conducted to check the time taken for the active ingredient in a drug to release into the body and help predict how the drug performs inside the body. The company initiated the Class II recall on July 24, 2014. The product was manufactured by Wockhardt in Mumbai and distributed by Wockhardt USA LLC in Parsippany, New Jersey.

In May, Wockhardt recalled 109,744 bottles of metoprolol after it failed an almost similar dissolution test. In June, the company again recalled 8712 bottles due to failure in dissolution test. Two of the company’s plants at Waluj and Chikalthana are under an FDA import ban regarding violations of the manufacturing standards. Its Morton Grove Chicago plant was also issued a Form 483 earlier this year. IGMPI