FDA, this morning, sent warning letters to nine pharmaceutical companies that are manufacturing and marketing 14 unapproved pain tablets. The drugs in question are prescription unapproved products that include high concentrate morphine sulfate oral solutions and immediate release tablets containing morphine sulfate, hydromorphone, or oxycodone.
The letters stated that the drug firms must cease and desist all production and respond to FDA’s inquiry. The companies now have 60 days to stop making the drugs and 90 days to stop distribution. If they fail to comply, FDA can cease the product, get an injunction against the company, and file criminal charges.
Consumers have a right to expect that their drugs meet the FDAâ€™s safety and effectiveness standards,â€ stated Janet Woodcock, director of the FDAâ€™s Center for Drug Evaluation and Research, in a release. â€œDoctors 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.
Companies receiving warning letters include:
Boehringer Ingelheim Roxane, Cody Laboratories, Glenmark Pharmaceuticals, Lannett Company, Lehigh Valley Technologies, Mallinckrodt Pharmaceuticals Group, Physicians Total Care, Roxane Laboratories, and Xanodyne Pharmaceuticals.