North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding 2022-04-27 Health serious FDA
Health · FDA · Recall #FDA-D-0780-2022
PT-141 (Bremelanotide Acetate) 10 mg/mL (2 mL) Injection, 2mL vials, Rx Only, Farmakeio… Recall
Issued April 27, 2022 · North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding
In April 2022, North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding recalled the PT-141 (Bremelanotide Acetate) 10 mg/mL (2 mL) Injection, 2mL vials, Rx Only, Farmakeio…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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 you should do
- 1 Stop using PT-141 (Bremelanotide Acetate) 10 mg/mL (2 mL) Injection, 2mL vials, Rx Only, Farmakeio… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding
- Category
- Health
- Recall date
- April 27, 2022
- Units affected
- Not reported
- Sold at
- Nationwide within United States
- Recall number
- FDA-D-0780-2022
- Made in
- United States
- Issuing agency
- FDA
In context
- North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding has 1 recall in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 870th Health recall we've logged in 2022.