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FDA Issues Warning Letters Regarding Unapproved Narcotics

Apr 1, 2009 | Parker Waichman LLP The U.S. Food and Drug Administration (FDA) just released an announcement that it is acting to stop the marketing of some unapproved prescription narcotic medications and warned nine companies to stop manufacturing 14 unapproved narcotic drugs that are marketed in several dosage forms and are widely used to treat pain.

The FDA's warning letters notified the companies they may be subject to enforcement action if they do not stop manufacturing and distributing unapproved prescription products that contain high concentrate morphine sulfate oral solutions and immediate release tablets containing morphine sulfate, hydromorphone, or oxycodone.

The FDA noted that its action does not include oxycodone capsules and explained that consumers prescribed narcotics for pain relief continue to have access to those narcotic products that the FDA has evaluated and determined to be safe and effective.  The FDA said that it has also determined that removal of the unapproved narcotic products will not create a shortage for consumers.

The following companies were sent warning letters by the FDA:
  • Boehringer Ingelheim Roxane, Inc., Columbus, Ohio
  • Cody Laboratories, Inc., Cody, Wyoming
  • Glenmark Pharmaceuticals Inc., Mahwah, New Jersey
  • Lannett Company, Inc., Philadelphia. Pennsylvania
  • Lehigh Valley Technologies, Inc., Allentown, Pennsylvania
  • Mallinckrodt Inc. Pharmaceuticals Group, St. Louis, Missouri
  • Physicians Total Care Inc., Tulsa, Oklahoma
  • Roxane Laboratories Inc., Columbus, Ohio
  • Xanodyne Pharmaceuticals Inc., Newport, Kentucky

The FDA explained that the warning letters are part of its initiative on marketed, unapproved drugs announced in June 2006.  At that time, the agency published a compliance policy guide describing its risk-based enforcement approach against illegally marketed unapproved drugs.  "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," Dr. Woodcock added.

Consumers who may be concerned that they are taking any of these products should refer to the FDA's Unapproved Drugs Web page at, which includes a list of manufacturers of these products and should also speak with a health care professional for detailed guidance on treatment options.  "We will continue to take aggressive action against those firms that do not have the required FDA approval for their drugs," said Deborah M. Autor, J.D., director of CDER's Office of Compliance. "Today's warning letters are another demonstration of our commitment to remove illegal, unapproved drugs from the market," Autor noted, said the FDA.

The FDA also reported that manufacturers have 60 days to stop producing these products and distributors have 90 days to stop shipping existing products.  Previously manufactured products may still be found on pharmacy shelves for a short time, the FDA warned.

Information on FDA-approved drugs can be accessed at:  Information on drugs marketed in the U.S. that do not have required FDA approval can be accessed at:

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