PT-141 (Bremelanotide Acetate) 10 mg/mL (2 mL) Injection, 2mL vials, Rx Only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081

Recall Number: D-0780-2022

Firm: North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding

Classification: Class II

Status: Terminated

Report Date: 20220427

Initiation Date: 20220405

Termination Date: 20231005

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

PT-141 (Bremelanotide Acetate) 10 mg/mL (2 mL) Injection, 2mL vials, Rx Only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081