FDA recall D-0918-2017

Complete Pharmacy and Medical Solutions LLC · Class I · drug

Product

Human Chorionic Gonadotropin, 15,000 IU per vial, lyophilized for injection, Rx only, Complete Pharmacy & Medical Solutions, Miami Lakes, FL 33014

Reason for recall

Non-sterility - presence of bacteria confirmed by outside laboratory after day 14.

Distribution

Nationwide and Puerto Rico

Key facts

Status
Ongoing
Initiation date
2016-04-02
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-0918-2017