The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-373-2013·Announced 2013-05-22

Green Valley Drugs Recalls Hydrogen Peroxide Injection Due to Sterility Concerns

FVS Holdings, Inc. dba. Green Valley Drugs is recalling Hydrogen Peroxide Injection due to a lack of assurance of sterility in compounded and repackaged products.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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 Hydrogen Peroxide Injection, including all strengths and presentations such as Hydrogen Peroxide 3% 30 mL. The recall involves 140 vials distributed nationwide. Specific lot numbers include 20130225-H (Exp 5/25/2013), 20130130-I (Exp 4/30/2013), and 20130311-I (Exp 6/11/2013).

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 as the reason for the action.

Consumers and healthcare providers should stop using the affected products and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
Hydrogen Peroxide Injection, all strengths and all presentations including Hydrogen Peroxide 3% 30 mL, 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
140

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 (6)

  • Lot #: 20130225-H
  • Exp 5/25/2013
  • 20130130-I
  • Exp 4/30/2013
  • 20130311-I
  • Exp 6/11/2013.

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 →

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