Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Ipamorelin Acetate/Sermorelin Acetate (1 mg/1 mg)/mL (10 mL) Injection Recalled by North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding Due to Lack of Assurance of Sterility: deviations from Current...

Date: April 5, 2022
Company: North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding directly.

Affected Products

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

Quantity: 189 vials

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding

North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding has 7 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report