North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding recalls PT-141 (Bremelanotide Acetate) 10 mg/mL (2 mL) Injection, 2mL vials, Rx Only, Farmakeio 1736 N Greenville Ave Richardson
Recalled April 27, 2022 · FDA recall D-0780-2022 · 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
43 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
PT-141 (Bremelanotide Acetate) 10 mg/mL (2 mL) Injection, 2mL vials, Rx Only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081
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 →