The Recall Desk
SevereFDA (Drugs)·D-378-2013·Announced 2013-05-22

FDA Recalls L-Glutathione Injection Due to Sterility Assurance Concerns

Green Valley Drugs is recalling L-Glutathione Injection vials because the FDA identified a lack of sterility assurance 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 severity score under the rubric for drug recalls involving potential serious health consequences.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a recall for L-Glutathione Injection products manufactured by FVS Holdings, Inc. dba. Green Valley Drugs. The recall covers all strengths and presentations of the product, including L-Glut-100 mg-30 mL, L-Glut-200 mg/30 mL, Glutathione 200 mg/ML P.F. 10 mL, and L-Glutathione-200-30 mL. A total of 430 vials were 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 products immediately. Specific lot numbers and expiration dates for the recalled items are listed in the official recall documentation. Patients should consult their healthcare provider for alternative treatment options.

The recalled product

Product
L-Glutathione Injection, all strengths and all presentations including a) L-Glut-100 mg-30 mL, b) L-Glut-200 mg/30 mL, c) Glutathione 200 mg/ML P.F. 10 mL, d) L-Glutathione-200-30 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 Medication
Hazard
Affected units
430

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 (8)

  • Lot #: a) L-Glut-100 mg-30 mL: 20130213-D
  • Exp 5/13/2013
  • b) L-Glut-200 mg/30 mL: 20130318-J
  • Exp 6/18/2013
  • 20130301-C
  • Exp 6/1/2013
  • d) L-Glutathione-200-30 mL
  • 30 mL: 20130205-A 5/5/2013

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

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