American Regent, Inc.: 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 S
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- Company / brand
- 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 / hazard
- Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- Nationwide within the U.S
- Recall initiated
- 2026-07-24
- Code info
- Lot #: 25295N0C0, Exp. Date: 04/30/2027.
- Product quantity
- 43,460 vials
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Shirley
- State
- NY
- Country
- United States
- Event id
- 99503
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