FDA recall D-0917-2017

Complete Pharmacy and Medical Solutions LLC · Class I · drug

Product

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.

Distribution

Distributed throughout Florida

Key facts

Status
Ongoing
Initiation date
2015-12-29
Report date
2017-06-21
Voluntary/Mandated
Voluntary: Firm initiated
Location
Miami Lakes, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0917-2017