North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding recalls BPC-157 2 mg/mL (5 mL) Injection, 5 mL vials, Rx Only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081
Recalled April 27, 2022 · FDA recall D-0776-2022 · 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
778 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
BPC-157 2 mg/mL (5 mL) Injection, 5 mL 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 →