FDA Recall D-0390-2024
Eugia US LLC · East Windsor, NJ
Class II Ongoing 814 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
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
Reason for recall
Failed Impurities/Degradation Specifications: Out of specification for organic impurities
Recall record
- Recall number
D-0390-2024- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide within the United States
- Recall initiated
- 2024-02-20
- Classified by FDA Center
- 2024-03-19
- FDA published
- 2024-03-27
- Recalling firm
- Eugia US LLC
- Firm location
- East Windsor, NJ
Drug identification
- Brand name(s)
- NICARDIPINE HYDROCHLORIDE
- Generic name(s)
- NICARDIPINE HYDROCHLORIDE
- Manufacturer(s)
- Eugia US LLC
- NDC(s)
55150-183- Route(s)
- INTRAVENOUS
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.