Drug product
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
D-0503-2024
Product summary
- Event
- Event 94621
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4,136 cartons (10 vials in each carton)
- Official record key
drug-enforcement:D-0503-2024
Official wording
Reason: Lack of Assurance of Sterility.
Code information: Lot #: 23087N0C0, Exp. Date 11/2024
Distribution pattern: UT only
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility