Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary
Compounding Law; Health Care; Awareness of all Types of Compounding Issues;
Pharmacy Benefit Managers (PBMs), Outsourcing Facilities
Food and Drug Administration and Compliance Issues
Tuesday, August 27, 2019
FDA requests recall of sterile compounded drug products produced by Pacifico National Inc., dba AmEx Pharmacy, reminds patients and health care professionals to stop using due to potential risks
The U.S. Food and Drug Administration is reminding patients and health care professionals not to use drug products intended to be sterile made by Pacifico National Inc., an outsourcing facility doing business as AmEx Pharmacy, in Melbourne, Florida. The drugs—which include compounded ophthalmic products among other drug products — pose unnecessary risks due to significant quality and sterility concerns.
“When the FDA becomes aware of drugs that have the potential to cause harm to American consumers, we will alert the public, Prior to today’s outreach, AmEx Pharmacy refused to recall all sterile drug products and has not adequately addressed FDA’s concern that it is manufacturing drugs that are not in line with the quality standards we’ve set, putting patients at risk,” said Acting FDA Commissioner Ned Sharpless, M.D. “We urge drug manufacturers and compounders to take appropriate action to ensure quality medicines as the agency continues our efforts to protect public health.”
An FDA inspection of AmEx Pharmacy’s facility found conditions that could cause the company’s drugs to become contaminated or otherwise pose risks to patients. As a result, the agency recommended on June 25that AmEx Pharmacy voluntarily recall all unexpired drugs intended to be ...