Recalls / Class II
Class IID-0390-2024
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
- Brand name
- Nicardipine Hydrochloride
- Generic name
- Nicardipine Hydrochloride
- Active ingredient
- Nicardipine Hydrochloride
- Route
- Intravenous
- NDC
- 55150-183
- FDA application
- ANDA211121
- Affected lot / code info
- Lot #: 3NC23002, Exp. Date 7/24; 3NC22013, 3NC22014, 3NC22015, 3NC22016, 3NC22017, 3NC22018, Exp. Date 2/24; 3NC22020, Exp. Date 3/24
Why it was recalled
Failed Impurities/Degradation Specifications: Out of specification for organic impurities
Recalling firm
- Firm
- Eugia US LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 279 Princeton Hightstown Rd, East Windsor, New Jersey 08520-1401
Distribution
- Quantity
- 335,940 vials
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2024-02-20
- FDA classified
- 2024-03-19
- Posted by FDA
- 2024-03-27
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0390-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.