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Recall Observatory FDA recall evidence

Drug product

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

D-0777-2022

April 05, 2022

Class II

Product summary

Firm
North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding
Event
Event 89954
Status
Terminated
Classification
Class II
Quantity
189 vials
Official record key
drug-enforcement:D-0777-2022

Official wording

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.

Code information: Lot #: 32961 BUD: 5/12/2022

Distribution pattern: Nationwide within United States

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    deviations from Current Good Manufacturing Practices
  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility