Drug product
Polidocanol Injection, all strengths and all presentations including a) Polidocanol 5% 30 mL, b) Polidocanol 1% 30 mL, c) Polidocanol 2% 30 mL, d) Polidocanol 3% 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
D-400-2013
Product summary
- Event
- Event 64879
- Status
- Terminated
- Classification
- Class II
- Quantity
- 109 vials
- Official record key
drug-enforcement:D-400-2013
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 #: Polidocanol 5% 30 mL: 20130319-I, Exp 6/19/2013; 20130326-H, Exp 6/26/2013; b) Polidocanol 1% 30 mL: 20130118-B, Exp 4/18/2013
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility