Drug product
Idoxuridine 0.1% Injection, compounded by Olympia Pharmacy, Orlando, FL
D-742-2013
Product summary
- Event
- Event 65360
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1
- Official record key
drug-enforcement:D-742-2013
Official wording
Reason: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Code information: L5703 Exp 11/30/2013
Distribution pattern: Nationwide and PR
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility