The Recall Desk
SevereFDA (Drugs)·D-357-2013·Announced 2013-05-22

Green Valley Drugs Recalls Dexamethasone Sodium Phosphate Injection Due to Sterility Concerns

Green Valley Drugs is recalling Dexamethasone Sodium Phosphate Injection because the compounding pharmacy could not ensure the sterility of the products.

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 injury or death from infection, meeting the criteria for a Severe rating.

Plain-English summary

FVS Holdings, Inc. dba. Green Valley Drugs is recalling Dexamethasone Sodium Phosphate Injection in all strengths and presentations. The recall involves 4,399 vials distributed nationwide. The specific products include Dexamethasone Sodium Phosphate 10 mg/1 mL, 10 mg/mL PF 1 mL, 4 mg/30 mL, and 4 mg/5 mL P.F.

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

Consumers and healthcare providers should stop using the recalled products and contact their healthcare provider for further instructions. The affected lot numbers and expiration dates are listed in the official recall notice.

The recalled product

Product
Dexamethasone Sodium Phosphate Injection, all strengths and all presentations including a) Dexamethasone Sodium Phosphate 10 mg/1 mL, b) Dexamethasone Sodium Phosphate 10 mg/mL PF 1 mL, c) Dexamethasone Sodium Phosphate 4 mg/30 mL, d) Dexamethasone-4 mg/5 mL P.F., Rx only, Green
Manufacturer
FVS Holdings, Inc. dba. Green Valley Drugs
Category
Drug — Injectable Sterile Compounded Drug
Hazard
Affected units
4,399

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 (13)

  • Lot #: a) Dexamethasone Sodium Phosphate 10mg/1ml: 20130402-F
  • Exp 7/2/2013
  • b) Dexamethasone Sodium Phosphate 10mg/ml PF 1ml: 20130307-H
  • Exp 6/7/2013
  • c) Dexamethasone Sodium Phosphate 4mg/30ml: 20130117-B
  • Exp 4/17/2013
  • 20130326-C
  • Exp 6/26/2013
  • 20130307-E
  • 20130221-D
  • Exp 5/21/2013
  • d) Dexamethasone-4mg/5ml P.F.: 20130328-L
  • Exp 6/28/2013

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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