FDA-Drug2022-04-27Class II
Melanotan II 1 mg/mL (10 mL) Injection, 10mL vials, Rx only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081 USA
North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding
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.
Sold states
Nationwide within United States
Affected count
35 vials
Manufactured in
1736 N Greenville Ave, Richardson, TX, United States
Products
Melanotan II 1 mg/mL (10 mL) Injection, 10mL vials, Rx only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081 USA
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0779-2022Don't want to check this manually?
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