The Recall Desk
SevereFDA (Drugs)·D-346-2013·Announced 2013-05-22

Green Valley Drugs Recalls Betamethasone Combination Injection Due to Sterility Concerns

Green Valley Drugs is recalling 295 vials and syringes of Betamethasone Combination Injection because the pharmacy could not ensure the products were sterile.

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. Per the rubric, FDA Class II recalls involving significant injury/property-damage reports or hospitalization are rated Severe (4). While specific injury reports are not detailed in the provided text, the lack of sterility assurance in injectable products represents a significant risk of serious harm, aligning with the Severe classification for Class II recalls with potential for significant injury.

Plain-English summary

FVS Holdings, Inc. dba. Green Valley Drugs is recalling 295 vials and syringes of Betamethasone Combination Injection. The recall covers all strengths and presentations, including Beta combo 6 mg/mL, 3 mL, Betameth_Combo_PF-6-2 Syr, and Betamethasone Combo 6 mg/mL Syr. 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 at the facility.

Consumers should stop using the recalled products and contact their healthcare provider or pharmacist for guidance. The recall is classified as FDA Class II, indicating a reasonable probability that use of the product may cause temporary or medically reversible health consequences.

The recalled product

Product
Betamethasone Combination Injection, all strengths and all presentations including a) Beta combo 6 mg/mL, 3 mL, b) Betameth_Combo_PF-6-2 Syr, and c) Betamethasone Combo 6 mg/mL Syr, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
Manufacturer
FVS Holdings, Inc. dba. Green Valley Drugs
Category
Drug — Injectable Sterile Compounded
Hazard
Affected units
295

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 (15)

  • Lot #: a) Beta combo: 20130123-B
  • Exp 4/23/201
  • b) Betameth_Combo_PF-6-2 Syr: 13031230GV1
  • Exp 6/12/2013
  • 13032060GV2
  • Exp 6/20/2013
  • 13011650GV7
  • Exp 4/16/2013
  • 13012330GV1
  • Exp 4/23/2013
  • 13020525Gv1
  • Exp 5/5/2013
  • c) Betamethasone Combo 6mg/ml Syr: 20130304-GV2
  • Exp 5/4/2013
  • 13031230GV1

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 →

Related recalls

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

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Same hazard · sterility failure

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