MedicineWatch US
Class II Recall

North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding

Product
Sermorelin Acetate 1 mg/mL (6 mL) Injection, 6 mL 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 #: 32963 BUD: 4/12/2022; 34824 BUD: 5/30/2022; 35130 BUD: 6/7/2022
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