niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 x 10 mL Single Dose Vials, Rx Only, For Intravenous Use Only, Mfd for: Civica, Inc., Lehi, UT 84043; Mfd by: American Regent, Inc., New Albany, OH 43054. NDC 72572-470-10
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot #: 23087N0C0, Exp. Date 11/2024
- 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:
- American Regent, Inc.
- Reason for Recall:
- Lack of Assurance of Sterility.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- completed
Product Information
Full Description:
niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 x 10 mL Single Dose Vials, Rx Only, For Intravenous Use Only, Mfd for: Civica, Inc., Lehi, UT 84043; Mfd by: American Regent, Inc., New Albany, OH 43054. NDC 72572-470-10
Product Codes/Lot Numbers:
Lot #: 23087N0C0, Exp. Date 11/2024
Distribution:
Distributed in: UT
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-0503-2024
Related Recalls
Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.
Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.
Presence of Particulate Matter: Potential for glass delamination from the vials.