Drug recall D-0391-2024
Product
Nicardipine Hydrochloride Injection, USP 25mg/mL (2.5 mg/mL) 10 mL vials, Distributed by: AuroMedics Pharma LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520, NDC 55150-183-11
Reason for recall
Failed Impurities/Degradation Specifications: Out of specification for organic impurities
Lots and codes
Lot #: 3NC22019, Exp. Date 2/24
Recall details
- Recalling firm
- Eugia US LLC, East Windsor, NJ
- Quantity
- 43,920 vials
- Distribution
- Nationwide within the United States
- Type
- Voluntary: Firm initiated
- Recall initiated
- February 20, 2024
Related products
- Nicardipine Hydrochloride – drug information
- NDC 55150-183 Nicardipine Hydrochloride · Nicardipine Hydrochloride 25 mg/10mL · Eugia US LLC