The Recall Desk
SevereFDA (Drugs)·D-379-2013·Announced 2013-05-22

Green Valley Drugs Recalls Lidocaine Injections Due to Sterility Concerns

Green Valley Drugs is recalling Lidocaine Injection products because the pharmacy could not ensure the sterility of the compounded and repackaged items.

What this means for you

Illness, injury, or structural failure has been reported. 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 Lidocaine Injection products in all strengths and presentations. The recall covers 3,946 vials distributed nationwide. The specific products include Lidocaine HCl-0.5%, Lidocaine HCl, Lidocaine 1%, Lidocaine 1% 50 mL, Lidocaine 2%, Lidocaine 2% 50 mL, and Lidocaine 2% 50 mL MDV.

The recall was initiated due to a lack of assurance of sterility. The FDA noted that all sterile products compounded, repackaged, and distributed by this compounding pharmacy are affected due to a lack of sterility assurance and concerns associated with the quality control processes.

Consumers and healthcare providers should stop using the affected products and contact their healthcare provider or the recalling firm for further instructions. The recall is classified as FDA Class II.

The recalled product

Product
Lidocaine Injection, all strengths and all presentations including a) Lidocaine _HCl-0.5%, b) Lidocaine HCl, c) Lidocaine 1%, d) Lidocaine 1% 50 mL, e) Lidocaine 2 %, f) Lidocaine 2% 50 mL, g) Lidocaine 2% 50 mL MDV, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson
Manufacturer
FVS Holdings, Inc. dba. Green Valley Drugs
Category
Drug — Injectable
Hazard
Affected units
3,946

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) Lidocaine _HCl-0.5%: 20130403-J
  • 20130403-F
  • 20130403-H
  • 20130403-G
  • 20130403-I
  • Exp 7/3/2013
  • 2013117-I
  • Exp 4/17/2013
  • b) Lidocaine HCl: 20130131-H
  • Exp 4/30/2013
  • c) Lidocaine 1%: 20130204-N
  • Exp 5/4/2013
  • 20130115-A
  • Exp 4/15/2013
  • 20130128-E
  • Exp 4/28/2013
  • 20130220-G
  • Exp 5/20/2013
  • 20130221-J
  • Exp 5/21/2013

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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