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Recall Observatory FDA recall evidence

Drug product

Testosterone Cypionate and Testosterone Propionate Injection, all strengths and all presentations including a) Testosterone cyp 200/test prop 20 mg 10 mL and b) Testosterone Cyp 200 mg/Test Prop 50 mg 10mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.

D-410-2013

April 10, 2013

Class II

Product summary

Firm
FVS Holdings, Inc. dba. Green Valley Drugs
Event
Event 64879
Status
Terminated
Classification
Class II
Quantity
51 vials
Official record key
drug-enforcement:D-410-2013

Official wording

Reason: Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.

Code information: Lot #: a) Testosterone cyp 200/test prop 20 mg 10 mL: 130102500AE, Exp 4/25/2013; b) Testosterone Cyp 200 mg/Test Prop 50 mg 10 mL: 20130305-1, Exp 6/5/2013

Distribution pattern: Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility