Drug product
Pentosan 250 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
D-768-2013
Product summary
- Event
- Event 65360
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 3
- Official record key
drug-enforcement:D-768-2013
Official wording
Reason: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Code information: K5629 Exp 11/30/13, C51013 Exp 9/10/13 and C5513 Exp 9/14/13
Distribution pattern: Nationwide and PR
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility