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FDAApril 5, 2022drug

PT-141 (Bremelanotide Acetate) 10 mg/mL (2 mL) Injection, 2mL vials, Rx Only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.

What to do

FDA enforcement status: Terminated

Brands named

north american custom laboratories llc dba farmakeio superior custom compoundingnorthnorth american

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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