FDA Warns Companies to Stop Making Unapproved Pain Killers

The U.S. Food and Drug Administration is warning companies to stop manufacturing and distributing unapproved narcotic drugs, which are sold in various forms and are widely used to treat pain.

The FDA has sent warning letters to nine manufacturers of 14 unapproved drugs, ordering them to stop circulating the products. The banned narcotic products include items containing high concentrate morphine sulfate oral solutions and immediate release tablets containing morphine sulfate, hydromorphone or oxycodone.

Companies which received the FDA warning letters include Boehringer Ingelheim Roxane, Inc. of Columbus, Ohio; Cody Laboratories, Inc. of Cody, Wyoming; Glenmark Pharmaceuticals Inc. of Mahwah, N.J.; Lannett Company, Inc. of Philadelphia; Lehigh Valley Technologies, Inc. of Allentown, Pa.; Mallinckrodt Inc. Pharmaceuticals Group of St. Louis; Physicians Total Care Inc. of Tulsa, Okla.; Roxane Laboratories Inc. of Columbus, Ohio; and Xanodyne Pharmaceuticals Inc. of Newport, Ky.

FDA Goes After Makers of Illegal, Unapproved Drugs

In June 2006, the FDA announced plans to crack down on companies that make or distribute unapproved drugs. The most recent action is part of that ongoing campaign, officials said.

“Consumers have a right to expect that their drugs meet the FDA’s safety and effectiveness standards,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research (CDER). “Doctors and patients are often unaware that not all drugs on the market are backed by FDA approval. It is a high priority for the FDA to remove these products from the market because they may be unsafe, ineffective, inappropriately labeled, or of poor quality.”

Removal of the unapproved narcotic drug products from the marketplace will not create a shortage of pain killers for patients, the FDA said.

The companies that received FDA warning letters now have 60 days to stop manufacturing the products. Distributors who handled the banned products have 90 days to stop shipping existing products. Previously manufactured products targeted by the FDA that have already reached stores may still be found on pharmacy shelves for a short time, officials said.

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