Why it was 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.
Product description
PT-141 (Bremelanotide Acetate) 10 mg/mL (2 mL) Injection, 2mL vials, Rx Only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081
Lot numbers, UPCs & expiration codes
Lot #: 32616 BUD: 4/4/2022; 34527 BUD: 5/24/2022
Where it was sold
Nationwide within United States
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0780-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 5, 2022
- FDA report date
- Apr 27, 2022
- Quantity
- 43 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding
Original FDA data
Every field from FDA enforcement report D-0780-2022, exactly as published.
Show all FDA fields
- City
- Richardson
- State
- TX
- Status
- Terminated
- Country
- United States
- Event ID
- 89954
- Address
- 1736 N Greenville Ave
- Code information
- Lot #: 32616 BUD: 4/4/2022; 34527 BUD: 5/24/2022
- Postal code
- 75081-1808
- Report date
- Apr 27, 2022
- Product type
- Drugs
- Recall number
- D-0780-2022
- Classification
- Class II
- Recalling firm
- North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding
- Product quantity
- 43 vials
- Termination date
- Oct 5, 2023
- Reason for recall
- Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- PT-141 (Bremelanotide Acetate) 10 mg/mL (2 mL) Injection, 2mL vials, Rx Only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081
- Distribution pattern
- Nationwide within United States
- Recall initiation date
- Apr 5, 2022
- Initial firm notification
- Letter
- Center classification date
- Apr 21, 2022