The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-412-2013·Announced 2013-05-22

Green Valley Drugs Recalls Sterile Testosterone and Nandrolone Injections

Green Valley Drugs is recalling specific lots of sterile hormone injections due to a lack of assurance of sterility and quality control concerns.

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 products, which poses a significant risk of serious injury or death from infection, meeting the criteria for a Severe rating.

Plain-English summary

FVS Holdings, Inc. dba. Green Valley Drugs is recalling Testosterone Propionate, Testosterone Cypionate, and Nandrolone Decanoate Injection. The recall includes all strengths and presentations, specifically including the Test Prop 100 mg/Test Cyp 50 mg/nandro dec 150 mg/ml formulation. The affected product is identified by Lot # 20130122-G with an expiration date of 4/22/2013. The product was 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.

Consumers and healthcare providers should stop using the affected product immediately. Patients should consult their healthcare providers for alternative treatment options. The recall is classified as FDA Class II.

The recalled product

Product
Testosterone Propionate, Testosterone Cypionate, and Nandrolone Decanoate Injection, all strengths and all presentations including Test Prop 100 mg/Test Cyp 50 mg/nandro dec 150 mg/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
2

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 #: 20130122-G
  • Exp 4/22/2013

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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