New Delhi, June 18, 2014 – Wockhardt Ltd. has issued a voluntary recall of 8,712 bottles of anti-hypertensive drug Metoprolol Succinate extended-release tablets from the US market due to failure of a dissolution test. According to US Food and Drug Administration (FDA), the recall is initiated by Wockhardt USA Inc, a subsidiary of Mumbai-based firm.
Wockhardt Ltd. is a global pharmaceutical and biotechnology company engaged in manufacturing formulations, biopharmaceuticals, nutrition products, vaccines and active pharmaceutical ingredients (APIs). The company is expertise in the manufacturing of pharmaceuticals and biopharmaceutical formulations as well as Active Pharmaceutical Ingredients (API). The 100 mg tablets (Metoprolol Succinate) in 100-count bottles were manufactured by Wockhardt Ltd and distributed in the US market by Wockhardt USA Inc.
According to USFDA, the recall is due to the failure of dissolution test observed at three month time point. The nationwide recall was initiated on April 10. FDA classified the recall as Class II recall, which is defined as “”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”. IGMPI
