The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-340-2013·Announced 2013-05-22

Green Valley Drugs Recalls Alpha Lipoic Acid Injection Due to Sterility Concerns

Green Valley Drugs is recalling Alpha Lipoic Acid 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 and involves a lack of sterility assurance in injectable products, which poses a significant risk of serious injury or infection, meeting the criteria for a Severe rating.

Plain-English summary

FVS Holdings, Inc. dba Green Valley Drugs is recalling 78 vials of Alpha Lipoic Acid Injection. The recall includes all strengths and presentations, including 25 mg/mL, 30 mL vials, which are prescription-only. The affected lots are 20130319-C (Exp 06/19/13) and 20130329-C (Exp 06/29/13). The products were distributed nationwide.

The recall was initiated due to a lack of assurance of sterility. The source text indicates that all sterile products compounded, repackaged, and distributed by this compounding pharmacy are affected due to concerns associated with the quality control processes.

Consumers and healthcare providers should stop using the affected Alpha Lipoic Acid Injection vials and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
Alpha Lipoic Acid Injection, all strengths and all presentations including 25 mg/mL, 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
Manufacturer
FVS Holdings, Inc. dba. Green Valley Drugs
Category
Drug — Injectable Compounded Drug
Hazard
Affected units
78

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 (4)

  • Lot #: 20130319-C
  • Exp 06/19/13
  • 20130329-C
  • Exp 06/29/13

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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