The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-364-2013·Announced 2013-05-22

Green Valley Drugs Recalls Estradiol Cypionate Injection Due to Sterility Concerns

Green Valley Drugs is recalling Estradiol Cypionate Injection because the pharmacy could not ensure the products were sterile. The recall covers all strengths and presentations distributed nationwide.

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. According to the rubric, FDA Class II recalls involving significant injury/property-damage reports or hospitalization are Severe. While no specific injuries are reported in the text, the lack of sterility assurance for injectable drugs poses a significant risk of serious infection, aligning with the Severe classification for Class II recalls with potential for serious harm.

Plain-English summary

FVS Holdings, Inc. dba. Green Valley Drugs is recalling Estradiol Cypionate Injection, all strengths and all presentations, including 5 mg/mL and 10 mg/mL vials. The recall is due to a lack of assurance of sterility for all sterile products compounded, repackaged, and distributed by the pharmacy. The issue stems from concerns associated with the pharmacy's quality control processes.

The affected products are prescription-only and were distributed nationwide. The recall includes 48 vials from specific lots: 20130226-F (Exp 5/26/2013) and 20130117-K (Exp 4/17/2013). The manufacturer is located in Henderson, Nevada.

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. No specific illnesses or injuries are reported in the source text.

The recalled product

Product
Estradiol Cypionate Injection, all strengths and all presentations including a) Estradiol Cypionate 5 mg/mL 10 mL and b) Estradiol Cypionate 10 mg/mL 10 ml, 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
48

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 (4)

  • Lot #: 20130226-F
  • Exp 5/26/2013
  • 20130117-K
  • 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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