Wockhardt recalls same drug for third time in the US since May – dnaindia.com
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Drug manufacturer Wockhardt has initiated another round of recall of its high blood pressure drug in the United States after it failed dissolution test. This is the company’s third recall of the same drug in the past four months.
The recall of 11,661 HDPE (high density polyethylene plastic bottles) of metoprolol succinate by the US subsidiary of Wockhardt started last month.
The United States Food and Drug Administration (FDA) in a notification on its website on August 27, classified the recall as Class II recall and said that Wockhardt USA has started recall of 100-count bottle (National Drug Code 64679-737-02) and 500-count bottle (NDC 64679-737-03) of prescription only drug metoprolol succinate extended-release tablets, USP 200 mg.
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 FDA website said the recalled lots were manufactured at a Wockhardt plant in Mumbai. Metoprolol is a generic form of AstraZeneca Plc’s branded drug Toprol.
Read more – dnaindia.com