Product Safety Recalls

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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

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-0780-2022
Event ID89954
DistributionNationwide within United States
Quantity43 vials
Recall ReasonLack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
Drug ClassificationClass II
Drug Code Info20220427
Recall Initiation Date20220405
Report Date20220427
Classification Date20220421
Address1736 N Greenville Ave
Richardson, TX 75081-1808
United States
Recalling FirmNorth American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding
Initial Notification Letter
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