Drug product
Sodium Tetradecyl Sulfate Injection, all strengths and all presentations including a) Sodium Tetradecyl Sulfate 3% 50 mL, b) Sodium Tetradecyl Sulfate 3% mL, c) Sodium Tetradecyl Sulfate-2% 30 mL, d) Sodium Tetradecyl Sulfate-2.5% 20 mL, e) Sodium Tetradecyl Sulfate 0.3% 30 mL, f) Sodium Tetradecyl Sulfate 1% 30 mL, 50 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
D-409-2013
Product summary
- Event
- Event 64879
- Status
- Terminated
- Classification
- Class II
- Quantity
- 203 vials
- Official record key
drug-enforcement:D-409-2013
Official wording
Reason: Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Code information: Lot #: a) Sodium Tetradecyl 3% 50 mL: 20130318-G, Exp 6/18/2013; b) Sodium Tetradecyl 3% mL: 20130218-G, Exp 5/18/2013; c) Sodium Tetradecyl-2% 30 mL: 20130122-B, Exp 4/22/2013; d) Sodium Tetradecyl-2.5% 20 mL: 20130114-D, Exp 4/14/2013; 20130117-C, Exp 4/17/2013 .
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility