Recall D-0780-2022
Description: PT-141 (Bremelanotide Acetate) 10 mg/mL (2 mL) Injection, 2mL vials, Rx Only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081
Recall D-0780-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0780-2022 |
| Event ID | 89954 |
| Distribution | Nationwide within United States |
| Quantity | 43 vials |
| Recall 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. |
| Drug Classification | Class II |
| Drug Code Info | 20220427 |
| Recall Initiation Date | 20220405 |
| Report Date | 20220427 |
| Classification Date | 20220421 |
| Address | 1736 N Greenville Ave Richardson, TX 75081-1808 United States |
| Recalling Firm | North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding |
| Initial Notification | Letter |
| Similar To |