Drug recall D-0802-2026

Class II Ongoing reported Aug 26, 2026

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 for recall

Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde

Lots and codes

Lot #: 25295N0C0, Exp. Date: 04/30/2027.

Recall details

Recalling firm
American Regent, Inc., Shirley, NY
Quantity
43,460 vials
Distribution
Nationwide within the U.S
Type
Voluntary: Firm initiated
Recall initiated
July 24, 2026

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