Recalls / Class II

Class IID-370-2013

Product

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.

Affected lot / code info

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

Why it was recalled

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.

Recalling firm

Firm

FVS Holdings, Inc. dba. Green Valley Drugs

Notification channel

Press Release

Type

Voluntary: Firm initiated

Address

1850 Whitney Mesa Dr, Suite 180, Henderson, Nevada 89014-2091

Distribution

Quantity

5255 vials and syringes

Distribution pattern

Nationwide

Timeline

Recall initiated

2013-04-10

FDA classified

2013-05-16

Posted by FDA

2013-05-22

Terminated

2014-03-21

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-370-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.