The Recall Desk
SevereFDA (Drugs)·D-348-2013·Announced 2013-05-22

Green Valley Drugs Recalls Betamethasone Sodium Phosphate Injection Due to Sterility Concerns

Green Valley Drugs is recalling Betamethasone Sodium Phosphate Injection because the pharmacy could not ensure the sterility of the compounded products.

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 (4) under the rubric, particularly given the risk of infection from non-sterile injectable products.

Plain-English summary

FVS Holdings, Inc. dba Green Valley Drugs is recalling Betamethasone Sodium Phosphate Injection in all strengths and presentations, including 6 mg/2 mL PF and 6 mg/mL. The recall involves 65 vials distributed nationwide. The specific lots affected are 20130405-F (Exp 7/5/2013) and 20130222-A (Exp 5/22/2013).

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 identified concerns associated with the quality control processes at the facility.

Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the recalling firm for instructions on how to return or dispose of the medication.

The recalled product

Product
Betamethasone Sodium Phosphate Injection, all strengths and all presentations including 6 mg/2 mL PF and 6 mg/mL; Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
Affected units
65

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 (5)

  • Lot #: 20130405-F
  • Exp 7/5/2013
  • 20130222-A
  • Exp 5/22/2013
  • 20130405-F

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 →