FDA is warning patients and health care professionals not to use products intended to be sterile produced by Pacifico National Inc., doing business as AmEx Pharmacy, Melbourne, Florida, due to a lack of sterility assurance. These drugs may pose a safety risk to patients.
Administration of a non-sterile drug intended to be sterile may result in serious and potentially life-threatening infections or death.
Health care professionals should immediately check their medical supplies, quarantine any drugs prepared by AmEx Pharmacy, and not administer or provide them to patients. FDA urges health care professionals, who obtained products from AmEx Pharmacy, to make alternative arrangements to obtain medications from sources that adhere to proper quality standards. Patients who have received any drug produced by AmEx Pharmacy and have concerns should contact their health care professional.
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FDA investigators recently inspected AmEx Pharmacy’s facility in May 2019 and observed conditions that could cause AmEx Pharmacy’s drugs to become contaminated or otherwise pose risks to patients.
On June 25, 2019, FDA recommended that AmEx Pharmacy voluntarily recall all unexpired drugs intended to be sterile and cease sterile operations until the company takes adequate corrective actions. However, AmEx Pharmacy has not initiated the recall.