WASHINGTON, D.C. — The U.S. Food and Drug Administration announced a reminder that doctors and other medical care providers must not use any purportedly sterile products Pacifico National, Inc., doing business as AmEx Pharmacy. The company is from Melbourne, FL. The FDA published a press release indicating that the drugs and medical products made by the compounding company are not sterile and pose a tremendous safety risk. The FDA also said that the agency has concerns about the quality of the medicines as well. The FDA singled out the company’s ophthalmic products as raising the greatest concerns for poor quality and lack of sterility.
The FDA inspected AmEx Pharmacy’s production facility and discovered manufacturing conditions that pose the risk of causing infections in patients who use the company’s compounded drugs. As a result of the FDA’s findings, the FDA suggested that AmEx Pharmacy should announce a voluntary recall of all unexpired products purporting to be sterile. Additionally, the FDA wanted AmEx Pharmacy to ensure that it would not resume operations until corrective measures were in place. AmEx Pharmacy refused to follow the FDA recommendations. Consequently, the company did not recall any of its unexpired drugs. Additionally, AmEx Pharmacy defiantly refused to ensure the quality of its products.
The FDA would not stand for the company’s defiance. Therefore, the FDA announced that it sent AmEx Pharmacy a formal request to proceed with a recall campaign designed to recall all unexpired lots of the potentially contaminated medication. The FDA also issued its warning to physicians about stopping use of the AmEx Pharmacy’s products. Administration of drugs believed to be sterile, especially into a patient’s eye during a medical procedure could lead to visual impairment and even loss of vision.
Compounded medications like those manufactured by AmEx pose a higher risk of adverse effects than other medicines because there is no mechanism for the FDA to review and analyze them before going to market.
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