Policyholder Services

Drug Alert – The FDA Advises Ophthalmologists to Cease Use of Specific Bevacizumab, Lidocaine Lots from Leiter’s Compounding Pharmacy

From the Academy:

The Academy is joining the U.S. Food and Drug Administration in alerting members nationwide to check their inventory and cease use of two medications produced by Leiter’s Compounding Pharmacy. Due to concerns of sterility assurance with the pharmacy’s independent testing laboratory, Leiter’s is recalling the following products:

Bevacizumab Lot. No. 08052013@1, expiry 11/03/13
Bevacizumab Lot No. 08052013@4, expiry 11/03/13
Lidocaine/phenylephrine Lot No. 07302013@6, expiry 10/28/13

The FDA reports that Leiter’s may have received inaccurate laboratory test results on the specified lot numbers. Leiter’s chose to voluntarily recall the products out of an abundance of caution. To date, Leiter’s has not received any reports of adverse events related to the recall.

Customers with affected items should discontinue use of the products and return the unused portion to Leiter’s Compounding Pharmacy. The pharmacy is also notifying affected customers of the recall by phone, email and mail. Contact Leiter’s with further questions at 800.292.6772.

Report any adverse events or side effects related to Leiter’s products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

Online at www.fda.gov/medwatch/report.htm

Download or call 800.332.1088 to request a reporting form. Return the form to the address provided therein or fax to 800.332.1078