Due to a lack of sterility assurance, the US Food and Drug Administration (FDA) has issued a warning not to use any sterile drug products—including bevacizumab (Avastin)—produced by Pacifico National Inc., which does business as AmEx Pharmacy in Melbourne, FL.

The warning stems from a May 2019 inspection of the pharmacy’s facility, where investigators observed conditions that could cause drugs to become contaminated or otherwise pose risks to patients. Health-care professionals should quarantine bevacizumab and any other sterile drugs prepared by AmEx Pharmacy, and not administer or provide them to patients. Alternative arrangements should be made to obtain medications from sources that adhere to proper quality standards.

Although the FDA recommended that AmEx Pharmacy voluntarily recall all unexpired drugs intended to be sterile and cease sterile operations on June 25, 2019, the pharmacy has yet to initiate a recall as of July 1, 2019. This latest setback comes just 2 months after AmEx voluntarily recalled 1 lot bevacizumab syringes following 3 reports of syringe malfunction.

Questions regarding this warning should be directed to AmEx Pharmacy at 1-800-644-9431 or by email at pharmacist@amexpharmacy.com from 9 a.m. to 6 p.m. ET, Monday through Friday. To date, the FDA is not aware of any reports of illness associated with the use of AmEx Pharmacy’s drugs.

Physicians and patients can report adverse reactions or quality issues to the FDA's MedWatch Adverse Event Reporting program:

• Online: Report adverse reactions or quality problems to the FDA’s MedWatch Adverse Event Reporting
• Mail or fax: Download the reporting form or call 1-800-332-1088 to request one. Complete and return to the address on the pre-addressed form or submit by fax to 1-800-FDA-0178