September 19, 2019
Sterility concerns have prompted Pacifico National Inc. to recall all lots of unexpired bevacizumab 1.25 mg/0.05 mL 31G injection and bevacizumab 2.5 mg/0.1 ml Normject TB injection repackaged and distributed by AmEx Pharmacy. The recall was included in the September 18, 2019, US Food and Drug Administration (FDA) Enforcement Report.
“These lots are being recalled out of an abundance of caution following an FDA inspection,” wrote Pacifico National Inc., which does business as AmEx Pharmacy, in a company announcement. “While all products associated with this voluntary recall passed compendial testing per USP 71 and USP 85, administration of a nonsterile drug product intended to be sterile may present the risk of infection.”
The product, which is used to treat patients with wet age-related macular degeneration and diabetic retinopathy, was distributed to ophthalmologist clinics throughout the United States, including Puerto Rico.
Pacifico National voluntarily initiated the recall August 30, 2019. The FDA designated the recall Class II on September 10, 2019. The classification suggests use of the product could cause temporary or medically reversible adverse health consequences. Although the likelihood is remote, a possibility of serious harm also exists.