FDA recall D-1155-2018

Pharmcore Inc. · Class II · drug

Product

Ipamorelin 9 mg 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-1155-2018