Drug product
Tripelennamine 20 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
D-788-2013
Product summary
- Event
- Event 65360
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2
- Official record key
drug-enforcement:D-788-2013
Official wording
Reason: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Code information: B5620 Exp 8/20/13 and A0322 Exp 12/31/13
Distribution pattern: Nationwide and PR
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility