Product Detail

Product Description
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.

Recall Number D-413-2013

Classification Class II

Code Info 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

Product Distributed Qty 3727 vials and syringes

Reason For Recall 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.

Event Detail

Event Id 64879


Product Type Drugs

Status Ongoing

Recalling Firm FVS Holdings, Inc. dba. Green Valley Drugs, Henderson, NV, USA

Voluntary / Mandated Voluntary: Firm Initiated

Recall Initiation Date 2013-04-10

Initial Firm Notification of Consignee or Public Press Release

Distribution Pattern Nationwide