Glenmark Pharmaceuticals has voluntarily recalled 24 generic prescription drugs distributed in the U.S. following concerns about potential cross-contamination at a manufacturing facility in Pithampur, India.
The recall follows an FDA inspection in February that found cleaning and testing lapses, according to federal records and an investigation by ProPublica.
Here are four more notes:
- The Class II recall, initiated March 13, covers 148 lots of tablets and capsules made between 2021 and 2023, according to an FDA enforcement report.
- The recalled drugs include treatments for conditions such as epilepsy, diabetes, multiple sclerosis, high blood pressure and heart disease.
- The recall stems from concerns of possible cross contamination. In a March 13 letter to wholesalers, Thomas Callaghan, Glenmark’s director of regulatory affairs, disclosed that 148 drug batches had been manufactured in a shared facility with ezetimibe and a combination of ezetimibe and simvastin, both cholesterol-lowering medications, ProPublica reported April 16. Because ezetimibe contains a beta-lactam ring, which, in some drugs, is linked to life-threatening allergic reactions, the FDA requires protocols to prevent contamination.
Glenmark told manufacturers it found no evidence that the drugs posed such risk, but initiated the recall “out of an abundance of caution.” - ProPublica previously found that the Pithampur facility was linked to a disproportionate number of U.S. recalls involving pills that failed to dissolve properly and in some cases involved fatal consequences.
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