Drug product
Vitamin B12 (3000 mcg/ml & 5000 mcg/ml) Injection, compounded by Olympia Pharmacy, Orlando, FL
D-791-2013
Product summary
- Event
- Event 65360
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2
- Official record key
drug-enforcement:D-791-2013
Official wording
Reason: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Code information: B0020 Exp 8/20/13 and C31011 Exp 9/10/13
Distribution pattern: Nationwide and PR
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility