The Recall Desk
SevereFDA (Drugs)·D-404-2013·Announced 2013-05-22

Green Valley Drugs Recalls Sodium Chloride and Dexamethasone Injection

Green Valley Drugs is recalling 950 syringes of Sodium Chloride and Dexamethasone Injection due to lack of assurance of sterility and quality control concerns.

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 in injectable products, which poses a significant risk of serious injury or infection.

Plain-English summary

FVS Holdings, Inc. dba. Green Valley Drugs is recalling 950 syringes of Sodium Chloride and Dexamethasone Injection, all strengths and presentations. The affected products include SOD_CHLOR-DEXAMETH-0.9-10-3 and SOD_CHLORIDE/DEXAMETH syringe 0.9-10-3, which are prescription-only items 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.

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

The recalled product

Product
Sodium Chloride and Dexamethasone Injection, all strengths and all presentations including a) SOD_CHLOR-DEXAMETH-0.9-10-3, b) SOD_CHLORIDE/DEXAMETH syringe 0.9-10-3, 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
950

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) SOD_CHLOR-DEXAMETH-0.9-10-3: 13011450GV3
  • Exp 4/14/2013
  • 13011450GV2
  • 13011760A
  • Exp 4/17/2013
  • 13012440
  • Exp 4/24/2013
  • 13020425GV2
  • Exp 5/4/2013
  • 2013021950GV1
  • Exp 5/19/2013
  • b) SOD_CHLORIDE/DEXAMETH syringe 0.9-10-3: 13031330GV1
  • Exp 6/13/2013
  • 13031460GV1
  • Exp 6/14/2013
  • 13032740GV2
  • Exp 6/27/2013
  • 20130327GV1
  • 13021920GV1
  • 130301100GV3

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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