The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-339-2013·Announced 2013-05-22

FDA Recalls Acetylcysteine Injection Due to Sterility Assurance Concerns

Green Valley Drugs is recalling Acetylcysteine Injection vials because the pharmacy could not ensure the products were sterile.

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, which corresponds to a Severe severity score under the rubric for significant injury or property damage risks, specifically involving sterility assurance failures in injectable drugs.

Plain-English summary

The U.S. Food and Drug Administration has issued a recall for Acetylcysteine Injection, including 100 mg/mL in 30 mL vials and 200 mg/mL in 30 mL and 50 mL vials. The product is prescribed only and was compounded, repackaged, and distributed by FVS Holdings, Inc. dba. Green Valley Drugs in Henderson, Nevada.

The recall was initiated due to a lack of assurance of sterility for all sterile products handled by the compounding pharmacy. The FDA cited concerns associated with the facility's quality control processes that prevented verification that the products were sterile.

The recall covers 93 vials distributed nationwide. Specific lot numbers include 20130129-J and 20130129-L (expiring 04/29/13) and 20130405-H (expiring 07/05/13). Patients and healthcare providers should stop using the recalled product and contact their healthcare provider for further instructions.

The recalled product

Product
Acetylcysteine Injection, all strengths and all presentations including 100 mg/mL in 30 mL vials and 200 mg/mL in 30 mL and 50 mL vials, 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
93

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 (5)

  • Lot #: 20130129-J
  • 20130129-L
  • Exp 04/29/13
  • 20130405-H
  • Exp 07/05/13.

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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