FDA Drug recall D-387-2013
Methylcobalamin Injection, all strengths and all presentations including a) Methylcobalamin 1000 mcg/mL in 10 mL, 30 mL, 50 mL, 60 mL, b) M…
- FDA Drug
- Class II
- terminated
- Published 2013-05-22
On 2013-05-22 the FDA classified a Class II recall of Methylcobalamin Injection, all strengths and all presentations including a) Methylcobalamin 1000 mcg/mL in 10 mL, 30 mL, 50 mL, 60 mL, b) M… by Fvs Holdings Dba Green Valley Drugs, citing lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associate….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-387-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-04-10 |
| Published | 2013-05-22 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Fvs Holdings Dba Green Valley Drugs |
| Distribution | US |
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.
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.
Identifiers
| code_info | Lot #: a) Methylcobalamin 1000 mcg: 20130208-G, Exp 5/8/2013; 20130118-G, Exp 4/18/2013; 20130129-E, Exp 4/29/2013; 201…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 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-387-2013%22
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