CLASS II Drug recall · Reported 27 Apr 2022 · FDA Enforcement Report
PT-141 (Bremelanotide Acetate) 10 mg/mL Injection vials recalled
North American Custom Laboratories is recalling PT-141 (Bremelanotide Acetate) 10 mg/mL Injection vials, distributed nationwide in the US. The recall was initiated on 5 Apr 2022 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0780-2022
- FDA event ID
- 89954
- Recalling firm
- North American Custom Laboratories, Richardson, TX
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 5 Apr 2022
- FDA classified
- 21 Apr 2022
- Reported
- 27 Apr 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 5 Apr 2022 | Recall initiated by company | |
| 21 Apr 2022 | Classified by FDA | +16 days |
| 27 Apr 2022 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
PT-141 (Bremelanotide Acetate) 10 mg/mL (2 mL) Injection, 2mL vials, Rx Only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081
Where it was distributed
Nationwide within United States
Questions about this recall
Why was it 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.
Which lots are affected?
Lot #: 32616 BUD: 4/4/2022; 34527 BUD: 5/24/2022
Where was it sold?
Nationwide within United States
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
6 other products · FDA event 89954More recalls from North American Custom Laboratories
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | LL-37 2 mg/mL Injection vials recalled by North American Custom | North American Custom Laboratories | Sterility | Nationwide |
| Drug | CLASS II | BPC-157 2 mg/mL Injection vials recalled by North American Custom | North American Custom Laboratories | Sterility | Nationwide |
| Drug | CLASS II | Sermorelin Acetate 1 mg/mL Injection vials recalled | North American Custom Laboratories | Sterility | Nationwide |
| Drug | CLASS II | Ipamorelin Acetate/Sermorelin Acetate (1 mg/1 mg)/mL Injection vials recalled | North American Custom Laboratories | Sterility | Nationwide |
| Drug | CLASS II | Melanotan II 1 mg/mL Injection vials recalled by North American Custom | North American Custom Laboratories | Sterility | Nationwide |