The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-345-2013·Announced 2013-05-22

Green Valley Drugs Recalls B-Complex Injections Due to Sterility Concerns

Green Valley Drugs is recalling 679 vials of B-Complex Injection products nationwide due to a lack of assurance of sterility and quality control concerns.

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 in injectable products, which poses a significant risk of serious injury or death from infection, meeting the criteria for a Severe rating.

Plain-English summary

FVS Holdings, Inc. dba. Green Valley Drugs is recalling 679 vials of B-Complex Injection products, including various strengths and presentations such as B-Complex Injection 30 mL, B-Complex PF 2 mL, and B-Complex Plus-100. The recall covers all sterile products compounded, repackaged, and distributed by the 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 should stop using the recalled products and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
B-Complex Injection, all strengths and all presentations including a) B-Complex Injection 30 mL; b) B-Complex PF 2 mL; c) B-Complex Plus-100; d) B-Complex_B12_30 mL; e) B-Complex-50-Methyl-30-Lido 30 mL; f) B-CompSuper-30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180…
Manufacturer
FVS Holdings, Inc. dba. Green Valley Drugs
Category
Drug — Injectable Compounded Medication
Hazard
Affected units
679

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 (18)

  • Lot #: a) B-Complex: 20130228-B
  • Exp 5/28/2013
  • 20130125-B
  • Exp 4/25/2013
  • b) B-Complex PF 2ml: 20130219-D
  • Exp 5/19/2013
  • 20130319 -J
  • Exp 6/19/2013
  • c) B-Complex Plus-100: 20130307-D
  • Exp 6/7/2013
  • 20130123-E
  • Exp 4/23/2013
  • d) B-Complex_B12_30ml: 20130212-F
  • Exp 5/12/2013
  • e) B-Complex-50-Methyl-30-Lido 30ml: 20130206-M
  • Exp 5/6/2013
  • f) B-CompSuper-30ml: 1302042000AE
  • Exp 5/4/2013.

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 →

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