Drug 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
D-0391-2024
Product summary
- Firm
- Eugia US LLC
- Event
- Event 94073
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 43,920 vials
- Official record key
drug-enforcement:D-0391-2024
Official wording
Reason: Failed Impurities/Degradation Specifications: Out of specification for organic impurities
Code information: Lot #: 3NC22019, Exp. Date 2/24
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Potency or specification failure
Out of specification