American Regent, Inc.: Nicardipine Hydrochloride Injection, Usp, 25 Mg/10ml (2.5 Mg/ml)
Recall Summary American Regent, Inc. is recalling niCARdipine Hydrochloride Injection (a blood pressure medication) in 10 mL vials because the product contains particulate matter including hair, glass, and/or paraformaldehyde. The recall affects all U.S. states and was distributed nationwide to hospitals and medical facilities.
- Recalling firm
- American Regent, Inc.
- Product
- niCARdipine Hydrochloride Injection, USP, 25 mg/10mL (2.5 mg/mL), packaged in a) 10 mL Single Dose Vial (NDC 72572-470-01) and b) 10x10 mL Single Dose Vials (NDC 72572-470-10), Rx Only, Mfd for: Civica, Inc., Lehi, UT, Mfd by: American Regent, Inc., New Albany, OH 43054.
- Reason
- Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
- Classification
- Class II
- Category
- drug recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-07-24
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Nationwide within the U.S
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/8938a5ad-088b-482e-93ce-518bd028b56a