FDA recall D-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.

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

Nationwide

Key facts

Status

Terminated

Initiation date

2013-04-10

Report date

2013-05-22

Termination date

2014-03-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

Henderson, NV, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-370-2013