Drug product
Stanozolol (50 mg/ml and 100 mg/ml) Injection, compounded by Olympia Pharmacy, Orlando, FL
D-783-2013
Product summary
- Event
- Event 65360
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 3
- Official record key
drug-enforcement:D-783-2013
Official wording
Reason: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Code information: 50mg/ml = Lots B5727 Exp 8/27/13, and C5708 Exp 9/8/13 // 100,g/ml =Lot C5706 Exp 9/6/13
Distribution pattern: Nationwide and PR
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility