The Recall Desk
SevereFDA (Drugs)·D-347-2013·Announced 2013-05-22

Green Valley Drugs Recalls BET-ACE-LIDO-6-2 Injection Due to Sterility Concerns

Green Valley Drugs is recalling BET-ACE-LIDO-6-2 Injection products because the pharmacy could not ensure the sterility of the compounded 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 for injectable products, which poses a significant risk of serious injury or death from infection.

Plain-English summary

FVS Holdings, Inc. dba. Green Valley Drugs is recalling BET-ACE-LIDO-6-2 Injection, all strengths and presentations, including 7 mL syringes and Betameth Combo 6 mg/mL Lidocaine 2% Syringes. The recall involves 435 vials and syringes that were distributed nationwide.

The recall was initiated due to a lack of assurance of sterility for all sterile products compounded, repackaged, and distributed by the pharmacy. The FDA cited concerns associated with the quality control processes at the facility.

Affected lots include 13012320-GV1, 13021840GV1, 13031150GV1, and 13011532, with expiration dates ranging from April 15, 2013, to June 11, 2013. Consumers and healthcare providers should stop using these products and contact their healthcare provider for further instructions.

The recalled product

Product
BET-ACE-LIDO-6-2 Injection, all strengths and all presentations including 7 mL syringe and Betameth Combo 6 mg/mL Lidocaine 2% Syringe, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
Manufacturer
FVS Holdings, Inc. dba. Green Valley Drugs
Category
Drug — Compounded Sterile Products
Hazard
Affected units
435

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 (9)

  • Lot #: 13012320-GV1
  • Exp 4/23/2013
  • 13021840GV1
  • Exp 5/18/2013
  • 13031150GV1
  • Exp 6/11/2013
  • 13012320-GV1
  • 13011532
  • Exp 4/15/2013.

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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