The Recall Desk
SevereFDA (Drugs)·D-405-2013·Announced 2013-05-22

Green Valley Drugs Recalls Sodium Bicarbonate and Lidocaine Injection

Green Valley Drugs is recalling 335 vials of Sodium Bicarbonate and Lidocaine Injection due to a lack of assurance of sterility in its compounding and quality control processes.

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 for an injectable drug, which poses a significant risk of serious injury or infection, meeting the criteria for a Severe rating.

Plain-English summary

FVS Holdings, Inc. dba. Green Valley Drugs is recalling 335 vials of Sodium Bicarbonate and Lidocaine Injection, all strengths and presentations. The recall was initiated because the compounding pharmacy lacked assurance of sterility for all sterile products it compounded, repackaged, and distributed, raising concerns about its quality control processes.

The affected product is distributed nationwide. Specific lot numbers and expiration dates are listed in the recall documentation, including lots expiring between April and June 2013.

Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the recalling firm for instructions on how to return or dispose of the medication.

The recalled product

Product
Sodium Bicarbonate and Lidocaine Injection, all strengths and all presentations including Sod-Bicarb-Lido-0.27-2.73-3 syr, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
Manufacturer
FVS Holdings, Inc. dba. Green Valley Drugs
Category
Drug — Injectable
Hazard
Affected units
335

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 (14)

  • Lot #: 20130226-GV4
  • Exp 5/26/2013
  • 13031150GV3
  • Exp 6/11/2013
  • 13031240GV4
  • Exp 6/12/2013
  • 13012325GV5
  • Exp 4/23/2013
  • 13021820GV3
  • Exp 5/18/2013
  • 13011520
  • Exp 4/15/2013
  • 13012425GV1
  • Exp 4/24/2013

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

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Same hazard · sterility failure

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