Aggressive pharmaceutical companies got a nasty message from the FDA warning about the illegal production of codeine in the form of an analgesic tab, the drug being a narcotic. The FDA’s crackdown on unapproved drugs began in June of 2006 as a part of an ongoing initiative. The following manufacturers were issued warning letters about further production of the tabs:
Codeine Sulfate Tablets, 30 mg, 60 mg from Cerovene Inc., Valley Cottage, N.Y.
Codeine Sulfate Tablets, 30 mg, 60 mg from Lehigh Valley Technologies Inc., Allentown, Penna.
Codeine Sulfate Tablets, 30 mg, 60 mg from Dava International Inc., Fort Lee, N.J.
Codeine Sulfate Tablets, 30 mg, 60 mg from Glenmark Generics Inc. USA, Mahwah, N.J.
According to Janet Woodcock, MD, director of the FDA Center for Drug Evaluation and Research, “Consumers deserve and expect that their drugs meet modern FDA standards for safety, effectiveness, labeling, and quality.” This does not mean, however, that the FDA will not issue temporary approvals of the drugs in the future in situations where there are shortages; the FDA does not foresee such issues. Click here to read an article from Medpage Today that discusses this study more.