AmEx Pharmacy Issues Voluntary Nationwide Recall for One Lot of Bevacizumab Amid Reports of a Defective Delivery System
UNITED STATES – According to a United States Food and Drug Administration (FDA) recall notification, AmEx Pharmacy has issued a voluntary nationwide recall of one lot of Bevacizumab following reports that the Monoject Syringe used to administer the medication is defective, potentially causing injury to patients.
What Are Bevacizumab Injections?
Bevacizumab is a medication used to treat Wet Age-related Macular Degeneration (when abnormal blood vessels under the retina begin to grow toward the macula) and Diabetic Retinopathy. Both of these eye conditions can lead to vision loss. Each does (syringe) of the medication is individually wrapped and labeled in a Tyvek pouch. Each pouch is placed in a labeled amber bag to protect the medication from light.
Specific Recall Information
On April 29, 2019, AmEx Pharmacy recalled one lot of Bevacizumab Injections (1.25mg/0.05mL 31G Injectible) at the consumer/user/patient level. Reports indicate that the Monoject Syringe that houses the medication can become difficult to express. When additional force is applied to express the medication, and when the needle is in the eye, patients are at risk of suffering injuries, including, but not limited to, vision loss, loss of an eye, and other serious and permanent eye injuries.
So far, AmEx Pharmacy has received three reports that the Monoject Syringe is difficult to express, and two of these reports resulted in adverse event reports to the FDA. All reports related to the one specific lot subject to the voluntary recall.
The particular lot affected by the voluntary recall is lot number 190212AB which appears on all labeling. The specific lot was distributed nationwide to opthalmologist clinics in Arizona, Illinois, Indiana, Kansas, Pennsylvania, Tennessee, Texas, and Wisconsin. AmEx Pharmacy will notify all customers by phone and overnight mail, providing instructions for returning and replacing the affected lots of Bevacizumab Injections.
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