Drug product
Papaverine 40 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
D-765-2013
Product summary
- Event
- Event 65360
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 6
- Official record key
drug-enforcement:D-765-2013
Official wording
Reason: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Code information: B0021 Exp 8/31/13, B0013 Exp 8/1/13, C5122 Exp 9/22/13, C51101 Exp 8/1/13, C5508 Exp 9/8/13, and C5119 Exp 9/19/13
Distribution pattern: Nationwide and PR
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility