Class II
Ongoing
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
This recall is currently active, issued March 27, 2024. It was issued by Eugia Us Llc.
- Company
- Eugia Us Llc
- Recall Initiated
- February 20, 2024
- Posted
- March 27, 2024
- Recall Number
- D-0390-2024
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 335,940 vials
- Firm Location
- East Windsor, NJ, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Failed Impurities/Degradation Specifications: Out of specification for organic impurities
Distribution
Nationwide within the United States
Lot / Code Info
Lot #: 3NC23002, Exp. Date 7/24; 3NC22013, 3NC22014, 3NC22015, 3NC22016, 3NC22017, 3NC22018, Exp. Date 2/24; 3NC22020, Exp. Date 3/24
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