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…
American Regent, Inc. · Lack of Assurance of Sterility.
- Status
- Terminated
- City
- New Albany
- State
- OH
- Country
- United States
- Classification
- Class II
- Product type
- Drugs
- Event ID
- 94621
- Recalling firm
- American Regent, Inc.
- Address 1
- 6610 New Albany Rd E
- Postal code
- 43054-8730
- Voluntary mandated
- Voluntary: Firm initiated
- Initial firm notification
- Letter
- Distribution pattern
- UT only
- Recall number
- D-0503-2024
- Product quantity
- 4,136 cartons (10 vials in each carton)
- Reason for recall
- Lack of Assurance of Sterility.
- Recall initiation date
- 20240514
- Center classification date
- 20240521
- Termination date
- 20251223
- Report date
- 20240529
- Code info
- Lot #: 23087N0C0, Exp. Date 11/2024
- 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
- Harmonized identifiers (openFDA)
- Application number
- ANDA090534
- Brand name
- NICARDIPINE HYDROCHLORIDE
- Generic name
- NICARDIPINE HYDROCHLORIDE
- Manufacturer name
- Civica, Inc.
- Product NDC
- 72572-470
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- INTRAVENOUS
- Substance name
- NICARDIPINE HYDROCHLORIDE
- RxCUI
- 858607
- SPL ID
- fba70df6-5d37-4a12-bce3-e6fb1b0c72b2
- SPL set ID
- 30fb3a4d-fa75-42fd-b4b6-2a21f202027f
- Package NDC
- 72572-470-01, 72572-470-10
- Is original packager
- true
- UNII
- K5BC5011K3