Drug product
Cyanocobalamin Injection, all strengths and all presentations including a) Cyanocobalamin 1000mcg, b) Cyanocobalamin 1000 mcg/mL in 1 mL, 10 mL, and 30 mL and 1 mL Preservative Free, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
D-355-2013
Product summary
- Event
- Event 64879
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6292 vials
- Official record key
drug-enforcement:D-355-2013
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) Cyanocobalamin 1000mcg: 20130214-C, Exp 5/14/2013; 20130220-B, Exp 5/20/2013; 20130226-D, Exp 5/26/2013; 20130226-E, Exp 5/26/2013; 20130226-L, Exp 5/26/2013; 20130125-E, Exp 4/25/2013; 20130125-D, Exp 4/25/2013; 20130125-C, Exp 4/25/2013; 20130125-F, Exp 4/25/2013; 20130211-M, Exp 5/11/2013; 20130214-B, Exp 5/14/2013; 20130221-D, Exp 5/21/2013; 20130225-K, Exp 5/25/2013; 20130214-B, Exp 5/14/2013; 20130226-C, Exp 5/26/2013; 20130226-I, Exp 5/26/2013; 20130225-M, Exp 5/25/2013; 20130225-N, Exp 5/25/2013; 20130225-J, Exp 5/25/2013; 20130225-C, Exp 5/25/2013; 20130204-G, Exp 5/4/2013; 20130204-F, Exp 5/4/2013; b) Cyanocobalamin 1000mcg 30ml: 20130325-D, Exp 6/25/2013; 20130325-C, Exp 6/25/2013; 20130326-E, Exp 6/26/2013; 20130326-I, Exp 6/26/2013; 20130329-L, Exp 6/29/2013; 20130329-M, Exp 6/29/2013; 20130306-Q, Exp 6/6/2013; 20130308-K, Exp 6/8/2013; 20130401-O, Exp 7/1/2013; 20130401-M, Exp 7/1/2013; 20130402-C, Exp 7/2/2013; 20130402-B, Exp 7/2/2013; 20130329-K, Exp 6/29/2013; 20130308-L, Exp 6/8/2013; 20130401-N, Exp 7/1/2013; 20130402-H, Exp 7/2/2013; 20130402-D, Exp 7/2/2013; 20130402-A, Exp 7/2/2013; 20130403-A, Exp 7/3/2013; 20130318-P, Exp 6/18/2013; 20130318-O, Exp 6/18/2013; 20130318-Q, Exp 6/18/2013; 20130319-B, Exp 6/19/2013; 20130226-B, Exp 5/26/2013; 20130318-A, Exp 6/18/2013
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility