Drug product
B-Complex Injection, all strengths and all presentations including a) B-Complex Injection 30 mL; b) B-Complex PF 2 mL; c) B-Complex Plus-100; d) B-Complex_B12_30 mL; e) B-Complex-50-Methyl-30-Lido 30 mL; f) B-CompSuper-30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
D-345-2013
Product summary
- Event
- Event 64879
- Status
- Terminated
- Classification
- Class II
- Quantity
- 679 vials
- Official record key
drug-enforcement:D-345-2013
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) B-Complex: 20130228-B, Exp 5/28/2013; 20130125-B, Exp 4/25/2013; b) B-Complex PF 2ml: 20130219-D, Exp 5/19/2013; 20130319 -J, Exp 6/19/2013; c) B-Complex Plus-100: 20130307-D, Exp 6/7/2013; 20130123-E, Exp 4/23/2013; d) B-Complex_B12_30ml: 20130212-F, Exp 5/12/2013; e) B-Complex-50-Methyl-30-Lido 30ml: 20130206-M, Exp 5/6/2013; f) B-CompSuper-30ml: 1302042000AE, Exp 5/4/2013.
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility