The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-343-2013·Announced 2013-05-22

Green Valley Drugs Recalls Betamethasone Injection Due to Sterility Concerns

Green Valley Drugs is recalling Betamethasone Acetate and Betamethasone Sodium Injection because the pharmacy lacked assurance of sterility in its quality control processes.

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 and involves a lack of sterility assurance in injectable drugs, which poses a significant risk of serious injury or death from infection.

Plain-English summary

FVS Holdings, Inc. dba. Green Valley Drugs is recalling Betamethasone Acetate and Betamethasone Sodium Injection, all strengths and presentations. The recall involves 4,368 vials distributed nationwide.

The recall was initiated due to a lack of assurance of sterility in 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 action.

Patients and healthcare providers should stop using the affected products and contact their healthcare provider for further instructions. The affected lot numbers are 20130114-A, 20130123-B, 20130124-A, 20130212-A, 20130321-B, and 20130319-M.

The recalled product

Product
Betamethasone Acetate and Betamethasone Sodium Injection, all strengths and all presentations including 6 mg/mL preservative free, 2 ml; 106 mg/mL 10 mL, and 6 mg/mL 5 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
Manufacturer
FVS Holdings, Inc. dba. Green Valley Drugs
Category
Drug — Injectable Steroids
Hazard
Affected units
4,368

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 (12)

  • Lot #: 20130114-A
  • Exp 4/14/2013
  • 20130123-B
  • Exp 4/23/2013
  • 20130124-A
  • Exp 4/24/2013
  • 20130212-A
  • Exp 5/12/2013
  • 20130321-B
  • Exp 6/21/2013
  • 20130319-M
  • Exp 6/19/2013

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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