D-370-2013 Class II Terminated

Recalled by FVS Holdings, Inc. dba. Green Valley Drugs — Henderson, NV

Recall Details

Product Type
Drugs
Report Date
May 22, 2013
Initiation Date
April 10, 2013
Termination Date
March 21, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
5255 vials and syringes

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.

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.

Distribution Pattern

Nationwide

Code Information

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