Drug product
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
D-0390-2024
Product summary
- Firm
- Eugia US LLC
- Event
- Event 94073
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 335,940 vials
- Official record key
drug-enforcement:D-0390-2024
Official wording
Reason: Failed Impurities/Degradation Specifications: Out of specification for organic impurities
Code information: Lot #: 3NC23002, Exp. Date 7/24; 3NC22013, 3NC22014, 3NC22015, 3NC22016, 3NC22017, 3NC22018, Exp. Date 2/24; 3NC22020, Exp. Date 3/24
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Potency or specification failure
Out of specification