The Recall Desk
SevereFDA (Drugs)·D-415-2013·Announced 2013-05-22

Green Valley Drugs Recalls Triamcinolone Injections Due to Sterility Concerns

Green Valley Drugs is recalling 1,423 vials of Triamcinolone 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 recall is classified as FDA Class II, which corresponds to a Severe severity score under the rubric for significant injury or property damage reports or high-risk contamination.

Plain-English summary

FVS Holdings, Inc. dba. Green Valley Drugs is recalling 1,423 vials of Triamcinolone Injection, all strengths and presentations. The affected products include Triamcinolone 40 mg/1 mL PF, Triamcinolone Acetonide 45 mg/mL, Triamcinolone 50 mg/mL 5 mL PF, Triamcinolone 45 mg/mL 10 mL and 30 mL, and Triamcinolone 40 mg/mL SDV PF 1 mL and 2 mL. The products 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 quality control processes as the reason for the recall.

Consumers and healthcare providers should stop using the affected products and contact their healthcare provider or the recalling firm for further instructions. The specific lot numbers and expiration dates for the affected products are listed in the structured product information.

The recalled product

Product
Triamcinolone Injection, all strengths and all presentations including a) Triamcinolone 40 mg/1 mL PF, b) Triamcinolone Acetonide 45 mg/mL, c) Triamcinolone 50 mg/mL 5 mL PF, d) Triamcinolone 45 mg/mL10 mL, 30 mL, e) Triamcinolone 40 mg/mL SDV PF 1 mL, 2 mL, Rx only, Green Valley
Manufacturer
FVS Holdings, Inc. dba. Green Valley Drugs
Category
Drug — Injectable Steroids
Hazard
Affected units
1,423

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 (11)

  • Lot #: a) Triamcinolone 40 mg/1 mL PF: 20130314-K
  • Exp 6/14/2013
  • b) Triamcinolone Acetonide 45 mg/mL: 20130129-I
  • Exp 4/29/2013
  • 20130208-B
  • Exp 5/8/2013
  • 20130314-K
  • 20130318-E
  • Exp 6/18/2013
  • 20130308-1
  • Exp 6/8/2013

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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