Clinical Updates — Clinical Updates
AmEx Pharmacy Recalls 1 Lot of Bevacizumab
The US Food and Drug Administration (FDA) reports that AmEx Pharmacy is voluntarily recalling 1 lot of bevacizumab 1.25mg/0.05mL 31G injectable.
According to the company, the Monoject syringe of this product may become difficult to express, and when additional force is applied while the needle is in the eye, the syringe may injure the patient.
The company’s recall states that the additional force needed to express the drug product could result in ocular damage while the needle is in the eye. AmEx Pharmacy notes it has received 3 reports associated with the recalled lot as being difficult to express; 2 of these reports have resulted in an Adverse Drug Event.
AmEx Pharmacy notes that the product is individually wrapped and labeled in a Tyvek pouch, then placed in a labeled amber bag to protect it from light.
The affected lot of bevacizumab 1.25mg/0.05m 3 lG injectable is 190212AB, BUD 5/13/2019, and can be identified by referencing that lot number, which prominently appears on all labeling.
This recalled lot was distributed to ophthalmology clinics in Arizona, Illinois, Indiana, Kansas, Pennsylvania, Tennessee, Texas, and Wisconsin.
According to the FDA, AmEx Pharmacy is notifying its consignees by telephone and overnight mail and is arranging for return/replacement of all recalled product.
If you have any of the affected product, AmEx Pharmacy advises you to stop use, remove it from inventory, and return it to the pharmacy.
If you have questions regarding this recall, contact AmEx Pharmacy at 800-644-9431 Monday through Friday between 9:00 AM and 6:00 PM Eastern Time or email firstname.lastname@example.org.
To report an adverse event or side effect related to the use of compounded products:
- Complete the online MedWatch Voluntary Reporting Form.
- Download the form or call 800-332-1088 to request the reporting form. Complete and return it to the address on the form, or fax to 800-FDA-0178.
- Complete the ASRS Adverse Event Report Form.
Published April 2019