Agency classClass IIOur severity:High FDA (Drugs)·D-0777-2022·Announced 2022-04-27

Ipamorelin and Sermorelin Injectable Medications Recalled Due to Sterility Deviations

North American Custom Laboratories is recalling 189 vials of Ipamorelin/Sermorelin injectable due to manufacturing deviations that call into question the sterility of this prescription medication.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This FDA Class II recall addresses manufacturing deviations that call into question the sterility of injectable medications. As a risk-of-harm situation with no illnesses or injuries reported in the source material, this meets the rubric criteria for a High severity rating.

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
Affected units: 189

Is your product affected?

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

Lot numbers (1)

Lot #: 32961 BUD: 5/12/2022

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 7 recalled by North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 7 products in this recall →

Same manufacturer · North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding

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Same hazard · lack of sterility