AUDIENCE: Consumers, Pharmacy
ISSUE: Beacon Hill Medical Pharmacy and FDA is notifying health professionals and consumers of the recall of all lots of certain sterile products. FDA has raised a question of sterility assurance for the affected products.The products were distributed nationwide to outlets including hospitals, clinics, and patients who have received orders by directly placing phone calls or faxed prescriptions to the Beacon Hill Medical pharmacy facility in Southfield,Michigan.
BACKGROUND: Microbial contamination of products intended to be sterile can lead to serious infections, which may be life-threatening.
RECOMMENDATION: The list of sterile injectable products compounded by Beacon Hill/Rxtra Solutions and under recall, in alphabetical order, organized by drug name and strength can be found in the firm's press release at the link below. The products can be identified by lot numbers starting with code 01012013@1 to 07262013@99.
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
[8/01/13 - Firm Press Release - Beacon Hill]
[8/01/13 - Product Photos - FDA]