Wockhardt Voluntarily Recalls Metoprolol Succinate for Failed Dissolution Testing

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; dissolution failures were found during testing of control samples at the four-hour time point. This is the third voluntary recall of metoprolol succinate, issued by Wockhardt this year.

The company initiated the nationwide Class II recall on July 24, 2014, which was reported in the US Food and Drug Administration’s weekly Enforcement Report of August 27, 2014.. The product was manufactured by Wockhardt in Mumbai and distributed by Wockhardt USA LLC in Parsippany, New Jersey, The recall applies to 11,661 bottles. A Class II recall is 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.

Wockhardt also issued a voluntary recall of  8712 bottles of metoprolol succinate for failed dissolution testing in April 2014 due to failure of dissolution testing observed at the three-month time point as well as recalled 109,000 bottles in April 2014 for failed dissolution testing at the nine-month point.

Source: FDA

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