Human Chorionic Gonadotropin recalled over sterility concerns

Recall date

December 29, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Complete Pharmacy and Medical Solutions LLC recalls Human Chorionic Gonadotropin, 125 IU HCG, in 0.5 ml syringe, subcutaneous administration, Rx only, Complete Pharmacy &…

Recall number

D-0917-2017

FDA classification

Class I

Brand / firm

Complete Pharmacy and Medical Solutions LLC

Sold / distributed

Distributed throughout Florida

Why it was recalled

Non-sterility: presence of mold confirmed by outside laboratory at the 14 day culture.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Human Chorionic Gonadotropin, 125 IU HCG, in 0.5 ml syringe, subcutaneous administration, Rx only, Complete Pharmacy & Medical Solutions, Miami Lakes, FL 33014