FDARecalled Mar 27, 2024 · #D-0391-2024
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
Hazard
Class II — temporary health risk
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Failed Impurities/Degradation Specifications: Out of specification for organic impurities Classification: Class II Distribution: Nationwide within the United States
Product details
- 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
- Type
- Drugs
- Manufacturer
- Eugia US LLC
- Model numbers
- 3NC22019
- UPCs
- —