Ipamorelin and Sermorelin Injectable Medications Recalled Due to Sterility Deviations

Plain-English summary

North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding is recalling 189 vials of Ipamorelin Acetate/Sermorelin Acetate (1 mg/1 mg)/mL injection, 10 mL vials (Lot #32961, BUD 5/12/2022). The affected vials were distributed nationwide within the United States.

The recall is due to deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of these products. These are prescription injectable medications intended to be sterile, and the manufacturing deviations have raised concerns about product sterility assurance.

This recall was issued by the U.S. Food and Drug Administration and classified as a Class II recall (FDA recall number D-0777-2022).

The recalled product

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

Manufacturer

North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding

Category

Drug — Injectable / Compounded Medication

Hazard

• lack-of-sterility
• manufacturing-defect

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

Distributed nationwide across the United States.

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