Drug product
VITAMIN B-COMPLEX INJECTABLE, VITAMIN B-COMPLEX SL SOLN and VITAMIN B-COMPLEX (PF) INJECTABLE, all configurations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
D-1009-2013
Product summary
- Event
- Event 65876
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-1009-2013
Official wording
Reason: Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Code information: 07022013@37, 01152013@32, 03012013@22, 03062013@15, 03122013@14, 04102013@4, 04242013@14, 04302013@2, 05242013@9, 06122013@26, 06122013@20, 07112013@16, 07232013@2
Distribution pattern: USA nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility