Why it was recalled
Failed Impurities/Degradation Specifications: Out of specification for organic impurities
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
Lot numbers, UPCs & expiration codes
Lot #: 3NC23002, Exp. Date 7/24; 3NC22013, 3NC22014, 3NC22015, 3NC22016, 3NC22017, 3NC22018, Exp. Date 2/24; 3NC22020, Exp. Date 3/24
Where it was sold
Nationwide within the United States
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0390-2024
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Feb 20, 2024
- FDA report date
- Mar 27, 2024
- Quantity
- 335,940 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Eugia US LLC
Original FDA data
Every field from FDA enforcement report D-0390-2024, exactly as published.
Show all FDA fields
- City
- East Windsor
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 94073
- Address
- 279 Princeton Hightstown Rd
- Code information
- Lot #: 3NC23002, Exp. Date 7/24; 3NC22013, 3NC22014, 3NC22015, 3NC22016, 3NC22017, 3NC22018, Exp. Date 2/24; 3NC22020, Exp. Date 3/24
- Postal code
- 08520-1401
- Report date
- Mar 27, 2024
- Product type
- Drugs
- Recall number
- D-0390-2024
- Classification
- Class II
- Recalling firm
- Eugia US LLC
- Product quantity
- 335,940 vials
- Reason for recall
- Failed Impurities/Degradation Specifications: Out of specification for organic impurities
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Feb 20, 2024
- Initial firm notification
- Letter
- Center classification date
- Mar 19, 2024