Drug product
Pyridoxine Hydrochloride Injection, all strengths and all presentations including Pyridoxine 100 mg/mL 30 mL, 50 mL, and 10 mL PF SDV, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
D-403-2013
Product summary
- Event
- Event 64879
- Status
- Terminated
- Classification
- Class II
- Quantity
- 319 vials
- Official record key
drug-enforcement:D-403-2013
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 #: 20130130-J, Exp 4/30/2013; 20130225-D, Exp 5/25/2013; 20130315-I, Exp 6/15/2013
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility