North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding
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
Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
Classification
Class II
Status
Terminated
Lot
Lot #: 32618 BUD: 4/4/2022; 34525 BUD: 5/24/2022
Date
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