SEP 12, 2013
Comprehensive Ophthalmology, Retina/Vitreous
Leiter's Compounding Pharmacy has voluntarily recalled certain lots of bevacizumab and lidocaine due to sterility concerns with the pharmacy's independent testing laboratory. Leiter’s has received no reports of adverse events.
The company is recalling:
• 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
During a recent inspection of Leiter's independent testing laboratory, Front Range Labs, FDA investigators observed methods used to assess sterility and other qualities that may have resulted in Leiter’s receiving inaccurate laboratory test results on the recalled lots.
The recalled products were dispensed directly to healthcare providers nationwide. The company is notifying customers of the recall by phone and mail. Customers that have any of the recalled medications should immediately discontinue using them and return the unused portion to Leiter’s.
Patients and healthcare providers with questions about this recall can contact Leiter’s at 1-800-292-6772, Monday through Friday between 8 a.m. and 5 p.m. Pacific Standard Time.
Adverse reactions experienced with the use of the recalled products may be reported to the FDA's MedWatch Adverse Event Reporting Program:
• Online at www.fda.gov/MedWatch/report.htm; or
• Download or call 800.332.1088 to request a reporting form. Return the form to the address provided therein or fax to 800.332.0178.