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North American Custom Laboratories, LLC Recalls
7 recalls on record · April 27, 2022 to April 27, 2022 · Drugs
April 27, 2022DrugsFDA
North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding recalls Sermorelin Acetate 1 mg/mL (6 mL) Injection, 6 mL vials, Rx only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081
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.
April 27, 2022DrugsFDA
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
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.
April 27, 2022DrugsFDA
North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding recalls Melanotan II 1 mg/mL (10 mL) Injection, 10mL vials, Rx only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081 USA
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.
April 27, 2022DrugsFDA
North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding recalls LL-37 2 mg/mL (5 mL) Injection, 5 mL vials, Rx only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081 USA
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.
April 27, 2022DrugsFDA
North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding recalls Ipamorelin Acetate/Sermorelin Acetate (1 mg/1 mg)/mL (10 mL) Injection, 10 mL vials, Rx Only, Farmakeio 1736 N Greenvill
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.
April 27, 2022DrugsFDA
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
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.
April 27, 2022DrugsFDA
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,
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.