The Recall Desk
SevereFDA (Drugs)·D-342-2013·Announced 2013-05-22

Green Valley Drugs Recalls Ascorbic Acid Injection Due to Sterility Concerns

Green Valley Drugs is recalling 2,682 vials of Ascorbic Acid Injection nationwide due to a lack of assurance of sterility and quality control concerns.

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 source text identifies the recall as FDA Class II. According to the severity rubric, FDA Class II recalls are classified as Severe (Score 4), particularly when involving significant risks such as sterility assurance failures in injectable products.

Plain-English summary

FVS Holdings, Inc. dba. Green Valley Drugs is recalling 2,682 vials of Ascorbic Acid Injection, prescription only, in all strengths and presentations. The recall covers multiple lot numbers with expiration dates ranging from April 2013 to July 2013. The product was distributed nationwide.

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 facility's quality control processes as the reason for the action.

Consumers and healthcare providers should stop using the affected Ascorbic Acid Injection vials and contact their pharmacist or the recalling firm for further instructions. The FDA classifies this recall as Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Ascorbic Acid Injection, all strengths and all presentations including a) 500 mg/mL, b) corn source 500 mg/mL, c) tapioca 500 mg/mL, d) cassave 500; 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
2,682

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 (20)

  • Lot #: a) 20130313-M
  • Exp 6/13/2013
  • 20130306-N
  • Exp 6/6/2013
  • 20130220-E
  • Exp 5/20/2013
  • 20130222-D
  • Exp 5/22/2013
  • 20130205-B
  • Exp 5/5/2013
  • 20130205-C
  • 20130222-F
  • 20130315-H
  • Exp 6/15/2013
  • 20130313-L
  • Exp 6/16/2013
  • 20130306-O
  • 20130328-A
  • Exp 6/28/2013
  • 20130404-F

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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