FDA announces Pacifico National Inc.’s, dba AmEx Pharmacy, voluntary recall of all sterile compounded drugs
Update [9/9/2019] FDA is alerting patients and health care professionals of Pacifico National Inc.’s, dba AmEx Pharmacy, voluntary recall of all unexpired drugs. AmEx Pharmacy has not been operational since July 27, 2019. Following FDA’s formal recall request on Aug. 27, 2019, AmEx Pharmacy agreed to recall all unexpired drugs intended to be sterile an continue to cease operations.
FDA warns patients and health care professionals not to use sterile products from Pacifico National Inc., dba AmEx Pharmacy
[6/28/2019] 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.
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.
To date, FDA is not aware of any reports of illness associated with the use of AmEx Pharmacy’s drugs. The agency asks health care professionals and patients to report unexpected side effects or quality problems associated with AmEx Pharmacy’s drugs to FDA’s MedWatch Adverse Event Reporting program:
- Complete and submit the report online at www.fda.gov/medwatch/report.htm; or
- Download and complete the form, then submit it via fax at 1-800-FDA-0178.
AmEx Pharmacy is registered as an outsourcing facility under section 503B of the FD&C Act. The Drug Quality and Security Act, signed into law on Nov. 27, 2013, added a new section 503B to the FD&C Act. Under section 503B, a compounder can elect to register as an outsourcing facility.