FDA recall D-1149-2018

Pharmcore Inc. · Class II · drug

Product

Human Chorionic Gonadotropin 20000 IU Vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009

Reason for recall

Lack of assurance of sterility.

Distribution

Nationwide

Key facts

Status
Terminated
Initiation date
2018-08-02
Report date
2018-09-05
Termination date
2022-01-18
Voluntary/Mandated
Voluntary: Firm initiated
Location
Hallandale Beach, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1149-2018