News|Articles|May 1, 2019

AmEx Pharmacy Recalls Bevacizumab 1.25mg/0.05mL 31G Injectable

The company is voluntarily recalling the product due to difficulties with the delivery system.

The company is voluntarily recalling the product due to difficulties with the delivery system.

AmEx Pharmacy announced on April 29, 2019 that it was voluntarily recalling one lot of Bevacizumab 1.25mg/0.05mL 31G Injectable because the Monoject Syringe may require additional force to express the drug. This additional force could cause injury to the eye, the company stated in a press release. Bevacizumab 1.25mg/0.05mL 31G Injectable is used to treat wet age-related macular degeneration and diabetic retinopathy.

The recalled product is individually wrapped, labeled in a Tyvek pouch, and contained in a labeled amber bag. The recalled lot, 190212AB, BUD 5/13/2019, was distributed nationwide to ophthalmologist clinics in Arizona, Illinois, Indiana, Kansas, Pennsylvania, Tennessee, Texas, and Wisconsin.

AmEx Pharmacy has received three reports associated with the recalled lot, two of which resulted in an adverse event. Adverse events may be reported to FDA via its MedWatch program.

Source: FDA

 


Related to this article

Regulatory Roundup—September 2026
The FDA opened an expedited IND pilot, tightened scrutiny of foreign trial data, and finalized a rule recognizing non-animal testing methods. In Europe, the EMA advanced pharmaceutical legislation reform, restricted 2 legacy products, and opened an injectable-iron safety review.
Pharma Logistician Using IoT Based On Blockchain | Image Credit: ©leowolfert -stock.adobe.com
Michael Levy, senior vice president, Digital & Innovation, USP, explains the digital supply chain in a preview of his upcoming CPHI Milan panel presentation, The Next Phase of Pharma Supply Chains.