The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-411-2013·Announced 2013-05-22

Green Valley Drugs Recalls Taurine Injection Due to Sterility Concerns

Green Valley Drugs is recalling Taurine Injection products because the compounding pharmacy lacked assurance of sterility and had quality control concerns.

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. Per the rubric, FDA Class II recalls involving significant injury/property-damage reports or structural defects are Severe; while no specific injuries are reported in the text, the lack of sterility assurance in a drug product represents a significant risk of harm, aligning with the Severe classification for Class II recalls with potential for serious health consequences.

Plain-English summary

FVS Holdings, Inc. dba. Green Valley Drugs is recalling Taurine Injection, all strengths and presentations, including Taurine 50 mg/mL, Taurine-50-30 mL, and Taurine-50 mg-30 mL. The recall covers 50 vials distributed nationwide. Specific lot numbers and expiration dates are listed in the structured product information.

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.

This is an FDA Class II recall. Consumers and healthcare providers should stop using the affected Taurine Injection products and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
Taurine Injection, all strengths and all presentations including a) Taurine 50 mg/mL, b) Taurine-50-30 mL, c) Taurine-50 mg-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
Hazard
Affected units
50

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 #: Taurine 50 mg/mL: 20130305-A
  • Exp 6/5/2013
  • Taurine-50-30 mL: 20130123-D
  • Exp 4/23/2013
  • Taurine-50mg-30 mL: 21030117-J
  • Exp 4/17/2013

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 →

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