D-387-2013 Class II Terminated
FDA drug recall D-387-2013 was initiated by FVS Holdings, Inc. dba. Green Valley Drugs on April 10, 2013 and is designated Class II. Reason for recall: 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 co… The recall status is terminated (terminated March 21, 2014). Affected quantity: 1343 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- May 22, 2013
- Initiation Date
- April 10, 2013
- Termination Date
- March 21, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1343 vials
Product Description
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.
Reason for Recall
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.
Distribution Pattern
Nationwide
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