FDA recall D-0777-2022

North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding · Class II · drug

Product

Ipamorelin Acetate/Sermorelin Acetate (1 mg/1 mg)/mL (10 mL) Injection, 10 mL vials, Rx Only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081

Reason for recall

Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.

Distribution

Nationwide within United States

Key facts

Status: Terminated
Initiation date: 2022-04-05
Report date: 2022-04-27
Termination date: 2023-10-05
Voluntary/Mandated: Voluntary: Firm initiated
Location: Richardson, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0777-2022