The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0779-2022·Announced 2022-04-27

Melanotan II Injectable Recalled for Manufacturing Sterility Defect

Melanotan II injection (35 vials) is being recalled nationwide due to manufacturing deviations that could compromise product sterility. Patients should not use affected lots and should contact their healthcare provider.

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 involves a risk-of-harm sterile injectable drug with manufacturing deviations that could compromise sterility. No illnesses have been reported, meeting the criteria for High severity per the rubric.

Plain-English summary

Melanotan II 1 mg/mL injectable medication has been recalled by the U.S. Food and Drug Administration. The recall involves 35 vials manufactured by North American Custom Laboratories, LLC (operating as FarmaKeio Superior Custom Compounding) and distributed nationwide. The affected lot numbers are 32610 (use-by date: 4/4/2022) and 35126 (use-by date: 6/7/2022).

The recall was initiated due to deviations from Current Good Manufacturing Practices (CGMP) that undermine confidence in the sterility of the product. As Melanotan II is an injectable medication intended for sterile administration, these manufacturing defects create a potential safety concern.

Patients or healthcare providers who have this medication should not use the affected lot numbers. Contact your healthcare provider or the FDA if you have questions about whether you have received this recalled product.

The recalled product

Product
Melanotan II 1 mg/mL (10 mL) Injection, 10mL vials, Rx only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081 USA
Manufacturer
North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding
Category
Drug
Hazard
Affected units
35

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 (2)

  • Lot #: 32610 BUD: 4/4/2022
  • 35126 BUD: 6/7/2022

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 →

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