Human Chorionic Gonadotropin, 125 IU HCG, in 0.5 ml syringe, subcutaneous administration, Rx only...

FDA Recall #D-0917-2017 — Class I — December 29, 2015

Recall #D-0917-2017 Date: December 29, 2015 Classification: Class I Status: Ongoing

Product Description

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

Reason for Recall

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

Recalling Firm

Complete Pharmacy and Medical Solutions LLC — Miami Lakes, FL

Classification

Class I — Reasonable probability of serious adverse health consequences or death.

Product Type

Drugs

Product Quantity

1890 syringes

Distribution

Distributed throughout Florida

Code Information

Lot # 2079ps5, Exp 02/01/2016

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated