On October 13, 2009, the FDA warned four companies to stop marketing unapproved codeine sulfate tablets. The drugs are opioid analgesics, commonly called narcotics, that are used to treat pain. The products never received FDA approval and the agency had no evidence that they were safe and effective. The manufacturers and distributors that received the warning letters for manufacturing and distributing codeine sulfate tablets, 30 mg and 60 mg are: (1) Lehigh Valley Technologies Inc., Allentown, Penn; (2) Cerovene Inc., Valley Cottage, N.Y. (3) Dava International Inc., Fort Lee, N.J. and (4) Glenmark Generics Inc. USA, Mahwah, N.J. Manufacturers have 90 days to cease manufacturing of new product and distributors have 180 days to cease further shipment of existing products.
SOURCE: FDA News Release
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