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
Reported: March 27, 2024 Initiated: February 20, 2024 #D-0390-2024
Product Description
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
Details
- Recalling Firm
- Eugia US LLC
- Units Affected
- 335,940 vials
- Distribution
- Nationwide within the United States
- Location
- East Windsor, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Eugia US LLC. Units affected: 335,940 vials.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications: Out of specification for organic impurities
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 27, 2024. Severity: Moderate. Recall number: D-0390-2024.
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