Indian Manufacturer Recalls Generics Due to Mix-Up

Glenmark Generics, U.S. subsidiary of India-based Glenmark Pharmaceuticals, has recalled a lot of generic ranitidine 150 mg tablets after a pharmacist complained that one bottle of the drug contained 50 mg metoprolol tartrate tablets instead of the intended drug.

The recall involved 2,904 bottles manufactured by Shasun Pharmaceuticals in Puducherry, India, for Glenmark, the FDA said in its latest enforcement report, making Shasun and Glenmark the latest Indian manufacturers to experience significant quality lapses recently.

In total, the FDA has banned imports from four Indian drugmakers over the past month, restricting imports from Sun Pharma, Marck Biosciences, Apotex and Canton Laboratories.

The problems are coming to light as the FDA is stepping up its regulatory presence in the country by sending seven new investigators to inspect facilities.

This year, the agency plans to conduct 40 percent more quality inspections overseas in India, China and other countries. The shift is part of an agency strategy to inspect foreign drug manufacturers as often as U.S.-based facilities.

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