Home / Recalls / North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding / D-0780-2022

D-0780-2022 Class II Terminated

Recalled by North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding — Richardson, TX

Recall Details

Product Type
Drugs
Report Date
April 27, 2022
Initiation Date
April 5, 2022
Termination Date
October 5, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
43 vials

Product Description

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

Reason for Recall

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

Distribution Pattern

Nationwide within United States

Code Information

Lot #: 32616 BUD: 4/4/2022; 34527 BUD: 5/24/2022

Other recalls by North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding

  • D-0776-2022 Class II — BPC-157 2 mg/mL (5 mL) Injection, 5 mL vials, Rx Only, Farmakeio 1736 N Greenvil (April 5, 2022)
  • D-0775-2022 Class II — ARA-290 (Cibinetide Acetate) 6 mg/mL (4 mL) Injection, 4 mL vials, Rx only, Farm (April 5, 2022)
  • D-0777-2022 Class II — Ipamorelin Acetate/Sermorelin Acetate (1 mg/1 mg)/mL (10 mL) Injection, 10 mL vi (April 5, 2022)
  • D-0781-2022 Class II — Sermorelin Acetate 1 mg/mL (6 mL) Injection, 6 mL vials, Rx only, Farmakeio 173 (April 5, 2022)
  • D-0779-2022 Class II — Melanotan II 1 mg/mL (10 mL) Injection, 10mL vials, Rx only, Farmakeio 1736 N Gr (April 5, 2022)
  • D-0778-2022 Class II — LL-37 2 mg/mL (5 mL) Injection, 5 mL vials, Rx only, Farmakeio 1736 N Greenvill (April 5, 2022)