The Recall Desk
SevereFDA (Drugs)·D-352-2013·Announced 2013-05-22

Green Valley Drugs Recalls Bupivacaine Injection Due to Sterility Concerns

Green Valley Drugs is recalling 756 vials of Bupivacaine Injection nationwide 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 the hazard involves a lack of sterility assurance for injectable drugs, which poses a significant risk of serious injury or infection.

Plain-English summary

FVS Holdings, Inc. dba. Green Valley Drugs is recalling 756 vials of Bupivacaine Injection, all strengths and presentations, including Bupivacaine Parabens Free 0.5% 50 mL and Bupivacaine PF 0.5% 30 mL SDV. The affected products are prescription-only and 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 facility's quality control processes as the reason for the action.

Healthcare providers and patients should stop using the affected vials and contact Green Valley Drugs for further instructions. Specific lot numbers and expiration dates for the recalled products are listed in the official recall notice.

The recalled product

Product
Bupivacaine Injection, all strengths and all presentations including a) Bupivacaine Parabens Free 0.5% 50 mL, and b) Bupivacaine PF 0.5% 30 mL SDV, 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
756

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 (12)

  • Lot #: a) Bupivacaine PF 0.5% 30 mL SDV: 20130318-C
  • Exp 6/18/2013
  • 20130319-F
  • Exp 6/19/2013
  • b) Bupivacaine Paraben Free 0.5% 50 mL: 20130212-E
  • Exp 5/12/2013
  • 20130124-F
  • Exp 4/24/2013
  • 20130214-G
  • Exp 5/14/2013
  • 20130320-E
  • Exp 6/20/2013

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

See all →

Same hazard · sterility

See all →