North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding recalls ARA-290 (Cibinetide Acetate) 6 mg/mL (4 mL) Injection, 4 mL vials, Rx only, Farmakeio 1736 N Greenville Ave Richardson,
Recalled April 27, 2022 · FDA recall D-0775-2022 · North American Custom Laboratories, LLC
Hazard
Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile. · FDA Class II
Units
28 vials
Sold at
Nationwide within United States
Description
Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
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
Manufacturer(s)
North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →