PT-141 recall: Sterility Concern
PT-141 (Bremelanotide Acetate) 10 mg/mL (2 mL) Injection, 2mL vials, Rx Only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081
Why was PT-141 recalled?
Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: 32616 BUD: 4/4/2022; 34527 BUD: 5/24/2022
- Product
- PT-141 (Bremelanotide Acetate) 10 mg/mL (2 mL) Injection, 2mL vials, Rx Only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081
- Recalling firm
- North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding
- Quantity
- 43 vials
- Distribution
- Nationwide within United States
- Recall date
- April 27, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)