Drug product
Methylcobalamin Injection, all strengths and all presentations including a) Methylcobalamin 1000 mcg/mL in 10 mL, 30 mL, 50 mL, 60 mL, b) Methylcobalamin 1000 mcg 30 mL, c) Methylcobalamin 5 mg/mL 30 mL, d) Methylcobalamin PF 1000 mcg/mL in 2 mL, 5 mL, 10 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
D-387-2013
Product summary
- Event
- Event 64879
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1343 vials
- Official record key
drug-enforcement:D-387-2013
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) Methylcobalamin 1000 mcg: 20130208-G, Exp 5/8/2013; 20130118-G, Exp 4/18/2013; 20130129-E, Exp 4/29/2013; 20130212-B, Exp 5/12/2013; 20130221-I , Exp 5/21/2013; 20130206-D, Exp 5/6/2013; 20130301-E, Exp 6/1/2013; 20130305-C, Exp 6/5/2013; b) Methylcobalamin 1000 mcg 30 mL: 20130308-G, Exp 6/8/2013; c) Methylcobalamin 5 mg/30 mL: 20130214-I, Exp 5/14/2013; d) Methylcobalamin PF 1000 mcg: 20130312-G, Exp 6/12/2013
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility