The Recall Desk
SevereFDA (Drugs)·D-409-2013·Announced 2013-05-22

Green Valley Drugs Recalls Sodium Tetradecyl Sulfate Injection for Sterility Concerns

Green Valley Drugs is recalling 203 vials of Sodium Tetradecyl Sulfate 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 and involves a lack of sterility assurance, which poses a significant risk of infection or serious injury, meeting the criteria for a Severe rating.

Plain-English summary

FVS Holdings, Inc. dba. Green Valley Drugs is recalling 203 vials of Sodium Tetradecyl Sulfate Injection, available in various strengths and presentations. The recall is due to a lack of assurance of sterility for all sterile products compounded, repackaged, and distributed by the pharmacy, as well as concerns associated with its quality control processes.

The affected products include Sodium Tetradecyl Sulfate 3% 50 mL, 3% mL, 2% 30 mL, 2.5% 20 mL, 0.3% 30 mL, and 1% 30 mL and 50 mL vials. The recall covers specific lots with expiration dates ranging from April 2013 to June 2013. The products were distributed nationwide.

Consumers and healthcare providers should stop using the recalled products and contact their healthcare provider or the recalling firm for further instructions. The FDA has classified this recall as Class II, indicating a reasonable probability that use of the product may cause temporary or medically reversible health consequences.

The recalled product

Product
Sodium Tetradecyl Sulfate Injection, all strengths and all presentations including a) Sodium Tetradecyl Sulfate 3% 50 mL, b) Sodium Tetradecyl Sulfate 3% mL, c) Sodium Tetradecyl Sulfate-2% 30 mL, d) Sodium Tetradecyl Sulfate-2.5% 20 mL, e) Sodium Tetradecyl Sulfate 0.3% 30 mL, f
Manufacturer
FVS Holdings, Inc. dba. Green Valley Drugs
Category
Drug — Injectable Sterile Compounded Drug
Hazard
Affected units
203

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 (10)

  • Lot #: a) Sodium Tetradecyl 3% 50 mL: 20130318-G
  • Exp 6/18/2013
  • b) Sodium Tetradecyl 3% mL: 20130218-G
  • Exp 5/18/2013
  • c) Sodium Tetradecyl-2% 30 mL: 20130122-B
  • Exp 4/22/2013
  • d) Sodium Tetradecyl-2.5% 20 mL: 20130114-D
  • Exp 4/14/2013
  • 20130117-C
  • 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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