Recalls / Class II
Class IID-0503-2024
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
- Brand name
- Nicardipine Hydrochloride
- Generic name
- Nicardipine Hydrochloride
- Active ingredient
- Nicardipine Hydrochloride
- Route
- Intravenous
- NDC
- 72572-470
- FDA application
- ANDA090534
- Affected lot / code info
- Lot #: 23087N0C0, Exp. Date 11/2024
Why it was recalled
Lack of Assurance of Sterility.
Recalling firm
- Firm
- American Regent, Inc.
- Manufacturer
- Civica, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 6610 New Albany Rd E, New Albany, Ohio 43054-8730
Distribution
- Quantity
- 4,136 cartons (10 vials in each carton)
- Distribution pattern
- UT only
Timeline
- Recall initiated
- 2024-05-14
- FDA classified
- 2024-05-21
- Posted by FDA
- 2024-05-29
- Terminated
- 2025-12-23
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0503-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.