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.
What this means for you
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
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.
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