Drug product
Guanabenz 8 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
D-737-2013
Product summary
- Event
- Event 65360
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 3
- Official record key
drug-enforcement:D-737-2013
Official wording
Reason: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Code information: C3621 Exp 9/21/13, L3618 Exp 10/31/13, and A0224 Exp 6/30/13
Distribution pattern: Nationwide and PR
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility