D-0390-2024 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- March 27, 2024
- Initiation Date
- February 20, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 335,940 vials
Product Description
Nicardipine Hydrochloride Injection (2.5mg/mL), US, 25mg per 10mL, 10mL Vial, Rx only, Distributed by: AuroMedics Pharma LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520 NDC 55150-183-10
Reason for Recall
Failed Impurities/Degradation Specifications: Out of specification for organic impurities
Distribution Pattern
Nationwide within the United States
Code Information
Lot #: 3NC23002, Exp. Date 7/24; 3NC22013, 3NC22014, 3NC22015, 3NC22016, 3NC22017, 3NC22018, Exp. Date 2/24; 3NC22020, Exp. Date 3/24