FDAFDA · Food and drugs·Recall number D-413-2013
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) Testosterone Cypionate 200 mg/mL 30 mL; g) Testosterone Cypionate Sesame 200 mg/10 mL; h) Testosterone Cyp 250/30 mL; i) Testosterone Cypionate 200 mg/mL; Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
Published May 22, 2013 · Recall initiated: April 10, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Press Release
Recall details
- Manufacturer
- FVS Holdings, Inc. dba. Green Valley Drugs
- Distributor
- Nationwide
- Lot
- 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; d) Testosterone Cypionate 200 mg 30 mL: 20130208-A, Exp 5/8/2013; 20130121-A, Exp 4/21/2013; 20130129-A, Exp 4/29/2013; 20130221-C, Exp 5/21/2013; 20130314-J, Exp 6/14/2013; 20130318-O, Exp 6/18/2013; 20130326-A, Exp 6/26/2013; 20130220-A, Exp 5/20/2013; 20130402-E, Exp 7/2/2013; e) Testosterone Cypionate 200 mg/mL: 20130304-J, Exp 6/4/2013; f) Testosterone Cypionate 200 mg/mL 30 mL: 20130215-C, Exp 5/15/2013; g) Testosterone Cypionate Sesame 200 mg/10 mL: 20130405-C, Exp 7/5/2013; h) Tetosterone Cyp 250/30 mL: 20130118-A, Exp 4/18/2013
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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