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North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding FDA Recalls

7 recalls on file across drugs, 0 of them Class I and 0 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
Melanotan II 1 mg/mL (10 mL) Injection, 10mL vials, Rx only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081 USAClass IIApr 5, 2022Lack of Assurance of Sterility: deviations from Current Good	Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into que	Class IIDrugs	Apr 5, 2022
ARA-290 (Cibinetide Acetate) 6 mg/mL (4 mL) Injection, 4 mL vials, Rx only, Farmakeio 1736 N Greenville Ave Richardson, Class IIApr 5, 2022Lack of Assurance of Sterility: deviations from Current Good	Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into que	Class IIDrugs	Apr 5, 2022
BPC-157 2 mg/mL (5 mL) Injection, 5 mL vials, Rx Only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081Class IIApr 5, 2022Lack of Assurance of Sterility: deviations from Current Good	Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into que	Class IIDrugs	Apr 5, 2022
Ipamorelin Acetate/Sermorelin Acetate (1 mg/1 mg)/mL (10 mL) Injection, 10 mL vials, Rx Only, Farmakeio 1736 N GreenvillClass IIApr 5, 2022Lack of Assurance of Sterility: deviations from Current Good	Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into que	Class IIDrugs	Apr 5, 2022
Sermorelin Acetate 1 mg/mL (6 mL) Injection, 6 mL vials, Rx only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081Class IIApr 5, 2022Lack of Assurance of Sterility: deviations from Current Good	Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into que	Class IIDrugs	Apr 5, 2022
LL-37 2 mg/mL (5 mL) Injection, 5 mL vials, Rx only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081 USAClass IIApr 5, 2022Lack of Assurance of Sterility: deviations from Current Good	Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into que	Class IIDrugs	Apr 5, 2022
PT-141 (Bremelanotide Acetate) 10 mg/mL (2 mL) Injection, 2mL vials, Rx Only, Farmakeio 1736 N Greenville Ave RichardsonClass IIApr 5, 2022Lack of Assurance of Sterility: deviations from Current Good	Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into que	Class IIDrugs	Apr 5, 2022

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