MedicineWatch US
Class II Recall

North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding

Product
PT-141 (Bremelanotide Acetate) 10 mg/mL (2 mL) Injection, 2mL vials, Rx Only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081
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 #: 32616 BUD: 4/4/2022; 34527 BUD: 5/24/2022
Date
Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.
North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding — Class II Recall | MedicineWatch US