Product Detail

Product Description
Human Chorionic Gonadotropin Injection, all strengths and all presentations including
a) HCG 1000u/mL,
b) HCG 1000u/mL 10mL,
c) HCG 1000u Folic 400 mcg Methyl 5 mg 10 mL,
d) HCG Kit 1 Day w/ Drug; HCT 750u/0.75 mL Pre-Filled Syringe,
e) HCG Syringe 150iu/0.15 mL,
f) HCG 1500u/1.5 mL Pre-Filled Syringe,
g) HCG 5000 unit/5 mL vial,
Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.

Recall Number D-370-2013

Classification Class II

Code Info Lot #:
a) HCG 1000u/mL: 20130319-E, Exp 5/19/2013;
b) HCG 1000u/mL 10mL: 20130221-J, Exp 4/21/2013

Product Distributed Qty 5255 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