FDA Warns Patients and Health Care Professionals not to use Sterile Products from Pacifico National Inc., dba AmEx Pharmacy

PUBLISHED: Jul 1, 2019
Relevant to: All Healthcare Organizations

The 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.

Health care professionals should immediately check their medical supplies, quarantine any drugs prepared by AmEx Pharmacy, and not administer or provide them to patients. The 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, the 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:

For more information, please visit: Pacifico National Inc., dba AmEx Pharmacy.

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