Recall D-0777-2022
Description: Ipamorelin Acetate/Sermorelin Acetate (1 mg/1 mg)/mL (10 mL) Injection, 10 mL vials, Rx Only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081
Recall D-0777-2022 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | D-0777-2022 |
Event ID | 89954 |
Distribution | Nationwide within United States |
Quantity | 189 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 |
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