SEP 04, 2019
Comprehensive Ophthalmology, Retina/Vitreous
AmEx Pharmacy has voluntarily recalled all lots of bevacizumab 1.25 mg/0.05 mL 31G injectable and bevacizumab 2.5 mg/0.1 ml Normject TB injectable. The recall is a precautionary measure after an FDA inspection revealed a potential for nonsterility.
In July, the regulatory agency warned consumers not to use any sterile drug products—including bevacizumab (Avastin)—produced by Pacifico National Inc., which does business as AmEx Pharmacy in Melbourne, Florida. That warning stemmed 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. Two months prior, AmEx voluntarily recalled 1 lot bevacizumab syringes following 3 reports of syringe malfunction.
Healthcare 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.
Questions regarding this warning should be directed to AmEx Pharmacy at 1-800-644-9431 or by email at firstname.lastname@example.org 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: