ARA-290 (Cibinetide Acetate) 6 mg/mL (4 mL) Injection, 4 mL vials, Rx only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081 USA

Recall Number: D-0775-2022

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.

ARA-290 (Cibinetide Acetate) 6 mg/mL (4 mL) Injection, 4 mL vials, Rx only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081 USA