Drug product
Phentolamine 20 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
D-770-2013
Product summary
- Event
- Event 65360
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 5
- Official record key
drug-enforcement:D-770-2013
Official wording
Reason: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Code information: B31012 Exp 8/31/13, B5102 Exp 8/10/13, C5228 Exp 9/22/13, B5012 Exp 12/31/13, and C5111 exp 9/11/13
Distribution pattern: Nationwide and PR
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility