FDA recall D-0775-2022

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

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-0775-2022