Mumbai-based drug company Wockhardt Ltd is recalling 109,744 bottles of a generic hypertension drug after it failed a dissolution test.
The FDA issued a Class II recall for metoprolol succinate, a generic form of the branded drug Toprol, produced by AstraZeneca.
Based on FDA standards, a Class II recall is issued when using or being exposed to the product may have temporary or medically reversible effects. In these cases, the probability of serious adverse health conditions is considered remote.
The FDA website justifies the recall based on the fact that the drug “Failed Dissolution Specifications: failure of dissolution test observed at nine month time point.”
The dissolution test helps determine how long a drug would take to release into the body, which helps predict drug performance.
While this drug recall is relatively minor, Wockhardt is already facing some scrutiny for regulatory troubles. Two of their manufacturing units have been banned from exporting drugs to the US in the last year, after the FDA found violations in the manufacturing standards and expressed suspicions that the company was compromising the quality of drugs.
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