The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-387-2013·Announced 2013-05-22

Green Valley Drugs Recalls Methylcobalamin Injections Due to Sterility Concerns

Green Valley Drugs is recalling 1,343 vials of Methylcobalamin Injection nationwide because the pharmacy could not ensure the products were sterile.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a lack of sterility assurance for injectable drugs, which poses a significant risk of serious injury or infection.

Plain-English summary

FVS Holdings, Inc. dba. Green Valley Drugs is recalling 1,343 vials of Methylcobalamin Injection, prescription only, in various strengths and presentations. The recall covers all sterile products compounded, repackaged, and distributed by this compounding pharmacy.

The recall was initiated due to a lack of assurance of sterility and concerns associated with the quality control processes. The affected products were distributed nationwide.

Consumers and healthcare providers should stop using the recalled products and contact their healthcare provider for further instructions.

The recalled product

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…
Manufacturer
FVS Holdings, Inc. dba. Green Valley Drugs
Category
Drug — Injectable
Hazard
Affected units
1,343

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 78 recalled by FVS Holdings, Inc. dba. Green Valley Drugs under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 78 products in this recall →

Related recalls

Same manufacturer · FVS Holdings, Inc. dba. Green Valley Drugs

See all →

Same hazard · sterility

See all →

Similar recalls