The Recall Desk
SevereFDA (Drugs)·D-402-2013·Announced 2013-05-22

FDA Recalls Green Valley Drugs Progesterone Injection for Sterility Concerns

Green Valley Drugs is recalling all Progesterone Injection products 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 (4) under the rubric, particularly given the risk of infection from non-sterile injectable products.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a Class II recall for Progesterone Injection products manufactured by FVS Holdings, Inc. dba. Green Valley Drugs. The recall includes all strengths and presentations of the drug, specifically Progesterone 100 mg/mL in 10 mL and 30 mL vials, and Progesterone 50 mg/mL in 30 mL vials. The affected lot is identified as 20130306-E with an expiration date of 6/6/2013. The recall covers 13 vials 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 facility's quality control processes as the reason for the action. This is a prescription-only medication.

Consumers and healthcare providers should stop using the affected products immediately. Patients should contact their healthcare provider for guidance on alternative treatments or further instructions. The recalling firm is FVS Holdings, Inc. dba. Green Valley Drugs, located in Henderson, Nevada.

The recalled product

Product
Progesterone Injection, all strengths and all presentations including a) Progesterone 100 mg/mL 10 mL, 30 mL b) Progesterone 50 mg/mL 30 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 Product
Hazard
Affected units
13

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 (2)

  • Lot #: a) Progesterone 100 mg/mL 10 mL: 20130306-E
  • Exp 6/6/2013

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 →

Related recalls

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

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Same hazard · sterility failure

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