The Recall Desk
SevereFDA (Drugs)·D-351-2013·Announced 2013-05-22

Green Valley Drugs Recalls Bupivacaine and Dexamethasone Injection for Sterility Concerns

Green Valley Drugs is recalling Bupivacaine and Dexamethasone 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, which poses a significant risk of serious health consequences such as infection.

Plain-English summary

FVS Holdings, Inc. dba. Green Valley Drugs is recalling Bupivacaine and Dexamethasone Injection, all strengths and presentations, including Bupiv_Dexameth-0.25-10.5. The recall involves 1,150 vials distributed nationwide. The product is prescription-only and was compounded, repackaged, and distributed by the pharmacy.

The recall was initiated due to a lack of assurance of sterility for all sterile products handled by the facility. The FDA cited concerns associated with the pharmacy's quality control processes as the reason for the action.

Healthcare providers and patients should stop using the affected products. Specific lot numbers and expiration dates are listed in the recall documentation. Consumers should contact their healthcare provider for guidance on alternative treatments or further instructions.

The recalled product

Product
Bupivacaine and Dexamethasone Injection, all strengths and all presentations including Bupiv_Dexameth-0.25-10.5; Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
Manufacturer
FVS Holdings, Inc. dba. Green Valley Drugs
Category
Drug — Compounded Sterile Preparations
Hazard
Affected units
1,150

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 #: 13011450GV4
  • 13011450GV1
  • Exp 4/14/2013
  • 13011760B
  • Exp 4/17/2013
  • 13012450
  • Exp 4/24/2013
  • 13021960GV2
  • Exp 5/19/2013
  • 2013021950GV2
  • 20130222GV3
  • Exp 5/22/2013
  • 13020450GV3
  • Exp 5/4/2013
  • 13020850GV2
  • Exp 5/8/2013
  • 13031330GV2
  • Exp 6/13/2013
  • 13032730GV1
  • Exp 6/27/2013

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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