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Avella Specialty Pharmacy Sterile Medications: Recall - Concerns Of Sterility Assurance At Testing Vendor
AUDIENCE: Consumer, Pharmacy, Patient, Health Professional
ISSUE: Avella Specialty Pharmacy is voluntarily recalling two compounded sterile medications, Bevacizumab 1.25 mg/0.05 mL PF and Vancomycin PF (BSS) 1%. The recall is a result of concerns of sterility assurance with the specialty pharmacy’s independent testing laboratory, Front Range Laboratories. To date, Avella has not received any reports of adverse events related to the recall.
BACKGROUND: Avella was notified that in a recent inspection of Front Range Labs, FDA investigators observed methods used to assess sterility and other qualities (e.g. strength and stability) which may have resulted in Avella receiving inaccurate laboratory test results on the specified lots. FDA has raised concerns that test results obtained from Front Range Labs may not be reliable. Therefore, Avella decided to conduct this voluntary recall out of an abundance of caution. The recalled products were dispensed directly to healthcare providers nationwide and the medications can be identified based on product label and corresponding medication name and lot number (see firm press release for lot numbers).
RECOMMENDATION: Patients should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Patients and healthcare providers with questions regarding this recall can contact Avella at (877) 738-0797 Monday through Friday between 6am and 6pm Pacific Standard Time or via e-mail at QA@xxxxxxxxxx.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Read the MedWatch Safety Alert, including links to the Firm Press Release at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm367719.htm
You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm
Update your subscriptions, modify your e-mail address, or stop subscriptions at any time on your Subscriber Preferences Page. You will need to use your e-mail address to log in. If you have questions or problems with the subscription service, please contact support@xxxxxxxxxxxxxxx.
This service is provided to you at no charge by U.S. Food & Drug Administration (FDA).
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