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
Reported: May 29, 2024 Initiated: May 14, 2024 #D-0503-2024
Product 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
Reason for Recall
Lack of Assurance of Sterility.
Details
- Recalling Firm
- American Regent, Inc.
- Units Affected
- 4,136 cartons (10 vials in each carton)
- Distribution
- UT only
- Location
- New Albany, OH
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by American Regent, Inc.. Units affected: 4,136 cartons (10 vials in each carton).
Why was this product recalled? ▼
Lack of Assurance of Sterility.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 29, 2024. Severity: Moderate. Recall number: D-0503-2024.
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