American Regent recalls 10 vials of niCARdipine Hydrochloride injection (25 mg/10 mL) due to lack of sterility assurance. This could cause infections if used improperly.
Lack of Assurance of Sterility.
American Regent is recalling 10 vials of niCARdipine Hydrochloride injection (25 mg/10 mL) because they may not be sterile. Using these vials could lead to infections if they are not properly handled.
The injection may not be sterile, which could lead to infections if used improperly. This is a risk for healthcare workers handling the product.
Healthcare professionals who use this injection for intravenous treatment. Patients receiving this medication under medical supervision.
Look for vials labeled 'niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 x 10 mL Single Dose Vials, Rx Only'. They were manufactured by American Regent, Inc. in New Albany, OH with NDC 72572-470-10 and lot number 23087N0C0.
Look for the label 'niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 x 10 mL Single Dose Vials, Rx Only' on the vial.
The product may not be sterile, which could lead to infections if used improperly. Do not use until the recall is resolved.
The recall does not specify a remedy, so contact American Regent for guidance.
Check the vial label for the product name, NDC 72572-470-10, and lot number 23087N0C0.
We’ve drafted a message you can send American Regent to request your refund or repair — edit it as you like.
Subject: Recall D-0503-2024 — American Regent American Regent Hello, I own a American Regent that is covered by recall D-0503-2024 from American Regent. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
