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
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot #: 3NC22019, Exp. Date 2/24
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Eugia US LLC
- Reason for Recall:
- Failed Impurities/Degradation Specifications: Out of specification for organic impurities
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
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
Product Codes/Lot Numbers:
Lot #: 3NC22019, Exp. Date 2/24
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-0391-2024
Related Recalls
Failed Stability Specifications: Out of specification results for the Color Absorbance test during 12 Month sample analysis.
Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.
Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.