niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 mL Single Dose Vial, Rx Only, American Regent, Inc., Shirley, NY 11967. NDC carton: 0517-0735-10 / NDC Vial: 0517-0735-01]
Reported: May 7, 2025 Initiated: April 18, 2025 #D-0399-2025
Product Description
niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 mL Single Dose Vial, Rx Only, American Regent, Inc., Shirley, NY 11967. NDC carton: 0517-0735-10 / NDC Vial: 0517-0735-01]
Reason for Recall
Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.
Details
- Recalling Firm
- American Regent, Inc.
- Units Affected
- 7,249 (cartons of 10 x 10 mL vials)
- Distribution
- Nationwide in the USA
- Location
- New Albany, OH
Frequently Asked Questions
What product was recalled? ▼
niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 mL Single Dose Vial, Rx Only, American Regent, Inc., Shirley, NY 11967. NDC carton: 0517-0735-10 / NDC Vial: 0517-0735-01]. Recalled by American Regent, Inc.. Units affected: 7,249 (cartons of 10 x 10 mL vials).
Why was this product recalled? ▼
Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 7, 2025. Severity: Moderate. Recall number: D-0399-2025.
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