Drug product
Phenylephrine 1 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
D-772-2013
Product summary
- Event
- Event 65360
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 4
- Official record key
drug-enforcement:D-772-2013
Official wording
Reason: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Code information: L5017 Exp 10/31/13, C51301 Exp 9/30/13, B5312 Exp 8/31/13, and A5209 Exp 11/01/13
Distribution pattern: Nationwide and PR
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility