Drug product
Sodium Tetradecyl Sulfate (0.125%, 1%, 2.5%, 3%, and 4%) Injection, compounded by Olympia Pharmacy, Orlando, FL
D-782-2013
Product summary
- Event
- Event 65360
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 10
- Official record key
drug-enforcement:D-782-2013
Official wording
Reason: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Code information: 0.125% Lot B3505 Exp 8/1/13 // 1% Lots C5001 Exp 9/30/13, C5406 Exp 9/4/13, and C5306 Exp 9/30/13 // 2.5% Lot C5101 Exp 9/30/13 // 3% Lots B5120 Exp 10/31/13, C5301 Exp 9/30/13, B5428 Exp 6/4/13, and C5212 Exp 9/21/13 // 4% Lot C5301 Exp 9/30/13
Distribution pattern: Nationwide and PR
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility