Beleaguered Indian generics maker Wockhardt has initiated a voluntary Class II recall of 11,661 bottles of metoprolol succinate, a generic version of AstraZeneca’s blood pressure drug Toprol-XL.
The recall was initiated July 24 because dissolution failures were found in control samples tested at the four-hour point, the FDA said in its enforcement report released last week.
Recalled were two lots of 100 and 500 count bottles of metoprolol succinate in its 200 mg dose. The product was made at Wockhardt’s Mumbai facility and distributed by its U.S. branch, the FDA said.
Wockhardt has initiated other recalls in recent months while simultaneously facing FDA accusations of poor manufacturing practices. The company did not respond to a request for comment by press time.
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