The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-413-2013·Announced 2013-05-22

Green Valley Drugs Recalls Testosterone Cypionate Injection Due to Sterility Concerns

Green Valley Drugs is recalling Testosterone Cypionate Injection vials and syringes because the compounding pharmacy could not ensure the products were sterile.

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 drugs, 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 3,727 vials and syringes of Testosterone Cypionate Injection. The recall covers all strengths and presentations of the drug, including various milligram and milliliter combinations, as well as sesame oil-based presentations. The products were distributed nationwide.

The recall was initiated due to a lack of assurance of sterility. The FDA cited concerns associated with the quality control processes used by the compounding pharmacy to compound, repackage, and distribute the sterile products.

Consumers who have purchased these products should stop using them and contact their healthcare provider or the recalling firm for instructions on how to return or dispose of the medication.

The recalled product

Product
Testosterone Cypionate Injection, all strengths and all presentations including a) Testosterone Cyp 200 mg/10 mL; b) Testosterone Cypionate 100 mg/10mL; c) Testosterone Cypionate 200 mg 10 mL; d) Testosterone Cypionate 200 mg 30 mL; e) Testosterone Cypionate 200 mg/mL; f)…
Manufacturer
FVS Holdings, Inc. dba. Green Valley Drugs
Category
Drug — Injectable Steroids
Hazard
Affected units
3,727

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 (20)

  • Lot #: a) Testosterone Cyp 200 mg/10 mL: 20130128-A
  • Exp 4/28/2013
  • b) Testosterone Cypionate 100 mg/10 mL: 20130226-G
  • Exp 5/26/2013
  • 130402100AE
  • Exp 7/2/2013
  • c) Testosterone Cypionate 200 mg 10 mL: 20130220-A
  • Exp 5/20/2013
  • 20130306-L
  • Exp 6/6/2013
  • 20130221-C
  • Exp 5/21/2013
  • 20130320-A
  • Exp 6/20/2013
  • 20130403-B
  • Exp 7/3/2013
  • 20130208-A
  • Exp 5/8/2013
  • 20130215-C
  • Exp 5/15/2013

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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