FDAnews Quality Training Advisor

Sun Conducts Massive Recall Due to Poor Quality of APIs

Aug. 27, 2014
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Sun Pharmaceutical recalled more than 450,000 drug units because the active ingredient wasn’t manufactured in compliance with FDA good manufacturing practices, creating another quality headache for the Indian drugmaker.

The company’s U.S. subsidiary, Caraco Pharmaceuticals, voluntarily recalled 340,553 units of its antibiotic cephalexin 500 mg and 113,677 units of the 250 mg dose of the drug, according to an FDA enforcement report issued Aug. 14.

The recall, initiated in June, is the latest quality problem to befall the Indian generics maker this year. Sun had to recall 41,127 bottles of the antidepressant venlafaxine HCl extended-release tablets because they didn’t properly dissolve.

Sun’s Karkhadi manufacturing plant was also warned earlier this year by the FDA for improperly deleting thousands of laboratory results. The agency slapped an import alert on products produced at the plant.

Sun initiated several corrective steps to address the agency’s concerns, said Managing Director Dilip Shanghvi during a June investor call.

Sun did not return a request for comment on the latest recall by press time.

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