Agency classClass IIOur severity:High FDA (Drugs)·D-0780-2022·Announced 2022-04-27

PT-141 Injection Recalled for Sterility Assurance Defect

PT-141 (Bremelanotide) injection vials are recalled due to manufacturing deviations that compromise sterility assurance. The FDA Class II recall involves 43 vials distributed nationwide.

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 is an FDA Class II recall of injectable medication with manufacturing deviations affecting sterility assurance. No illnesses or injuries have been reported, making the hazard theoretical; per the rubric, theoretical hazards without reported injury score at most 3 (High), though the injectable drug nature and sterility concern warrant this rating.

Plain-English summary

PT-141 (Bremelanotide Acetate) 10 mg/mL injection in 2 mL vials, manufactured by North American Custom Laboratories LLC dba FarmaKeio Superior Custom Compounding, is being recalled by the FDA. The recall affects 43 vials: Lot #32616 with Beyond Use Date of 4/4/2022 and Lot #34527 with Beyond Use Date of 5/24/2022.

The recall is due to deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of these products. As injectable medications intended to be sterile, compromised sterility assurance presents a safety risk.

The affected vials were distributed nationwide within the United States.

Patients or healthcare providers who possess vials of PT-141 from the affected lots should not use them and should contact their healthcare provider or North American Custom Laboratories LLC for further guidance.

The recalled product

Product: PT-141 (Bremelanotide Acetate) 10 mg/mL (2 mL) Injection, 2mL 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 Prescription
Hazard: lack-of-sterility
manufacturing-defect
Affected units: 43

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 #: 32616 BUD: 4/4/2022
34527 BUD: 5/24/2022

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