Drug product

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

D-0775-2022

April 05, 2022

Class II

Product summary

Firm: North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding
Event: Event 89954
Status: Terminated
Classification: Class II
Quantity: 28 vials
Official record key: drug-enforcement:D-0775-2022

Official wording

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

Code information: Lot #: 32618 BUD: 4/4/2022; 34525 BUD: 5/24/2022

Distribution pattern: Nationwide within United States

Derived failure modes

Manufacturing or process control
reason.manufacturing_process_control · v1.0.0

deviations from Current Good Manufacturing Practices
Sterility assurance
reason.sterility_assurance · v1.0.0

Lack of Assurance of Sterility