The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-368-2013·Announced 2013-05-22

Green Valley Drugs Recalls Gentamicin Injection Due to Sterility Concerns

Green Valley Drugs is recalling 1,140 vials of Gentamicin Injection nationwide due to a lack of assurance of sterility in its compounding and quality control processes.

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 in injectable drugs, 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 1,140 vials of Gentamicin Injection, all strengths and presentations, distributed nationwide. The recall involves specific lots of Gentamicin 40 mg/2 mL, Gentamicin 40 mg/30 mL, Gentamicin-40-20 mL, and Gentamicin-40 mg/mL-2 mL, all marked as prescription only.

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 identified concerns associated with the facility's quality control processes that compromised the sterility of the products.

Healthcare providers and patients should stop using the affected Gentamicin Injection vials immediately. The specific lot numbers and expiration dates are listed in the recall documentation. Consumers should contact their healthcare provider for guidance on alternative treatments.

The recalled product

Product
Gentamicin Injection, all strengths and all presentations including a) Gentamicin 40 mg/2 mL, b) Gentamicin 40 mg/30 mL, c) Gentamicin-40-20 mL, d) Gentamicin-40 mg/mL-2 mL, 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
1,140

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 (9)

  • Lot #: a) Gentamicin 40 mg/2 mL: 20130403-D
  • Exp 7/3/2013
  • 20130227-H
  • Exp 5/27/2013
  • b) Gentamicin 40 mg/30 mL: 20130204-E
  • Exp 5/4/2013
  • c) Gentamicin-40-20 mL: 20130204-E
  • d) Gentamicin-40 mg/mL-2 mL
  • 20130227-A

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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