FDAFDA · Food and drugs·Recall number 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
Published March 27, 2024 · Recall initiated: February 20, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Impurities/Degradation Specifications: Out of specification for organic impurities
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- NICARDIPINE HYDROCHLORIDE
- Manufacturer
- Eugia US LLC
- Distributor
- Nationwide within the United States
- UPC
- 0355150183111
- Lot
- Lot #: 3NC22019, Exp. Date 2/24
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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