The Recall Desk
SevereFDA (Drugs)·D-403-2013·Announced 2013-05-22

Green Valley Drugs Recalls Pyridoxine Hydrochloride Injection for Sterility Concerns

Green Valley Drugs is recalling Pyridoxine Hydrochloride Injection due to 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 recall is classified as FDA Class II, which corresponds to a Severe rating under the rubric for significant injury or property damage reports or high-risk contamination scenarios.

Plain-English summary

FVS Holdings, Inc. dba. Green Valley Drugs is recalling Pyridoxine Hydrochloride Injection, all strengths and presentations, including Pyridoxine 100 mg/mL in 30 mL, 50 mL, and 10 mL PF SDV vials. The recall involves 319 vials 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 quality control processes at the facility.

Affected lots include 20130130-J (Exp 4/30/2013), 20130225-D (Exp 5/25/2013), and 20130315-I (Exp 6/15/2013). Consumers and healthcare providers should stop using the affected products and contact their pharmacist or the recalling firm for further instructions.

The recalled product

Product
Pyridoxine Hydrochloride Injection, all strengths and all presentations including Pyridoxine 100 mg/mL 30 mL, 50 mL, and 10 mL PF SDV, 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
319

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 #: 20130130-J
  • Exp 4/30/2013
  • 20130225-D
  • Exp 5/25/2013
  • 20130315-I
  • Exp 6/15/2013

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 →

Related recalls

Same manufacturer · FVS Holdings, Inc. dba. Green Valley Drugs

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Same hazard · sterility

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