niCARdipine Hydrochloride Injection recall
FDA recall D-0503-2024 · initiated May 14, 2024
American Regent, Inc. recalled niCARdipine Hydrochloride Injection in May 2024 — an FDA Class II recall (D-0503-2024) because Lack of Assurance of Sterility.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Lack of Assurance of Sterility.
Sterility could not be assured
The maker could not guarantee the product was sterile. That matters most for injections and eye products, where a contaminated dose reaches past the body's defences.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 4,136 cartons (10 vials in each carton)
Details
- 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
- Recalling company
- American Regent, Inc.
- Classification
- Class II
- Status
- Terminated
- Type
- Voluntary: Firm initiated
- Distribution
- UT only
- Initiated
- May 14, 2024
- FDA report date
- May 29, 2024
Frequently asked
- Was niCARdipine Hydrochloride Injection recalled?
- American Regent, Inc. recalled niCARdipine Hydrochloride Injection in May 2024 — an FDA Class II recall (D-0503-2024) because Lack of Assurance of Sterility. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was niCARdipine Hydrochloride Injection recalled?
- Per the FDA enforcement record, the reason for recall D-0503-2024 was: Lack of Assurance of Sterility.
- Is a recalled niCARdipine Hydrochloride Injection dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of niCARdipine Hydrochloride Injection are affected?
- Distributed: UT only. The recall covers these lots — Lot #: 23087N0C0, Exp. Date 11/2024. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0503-2024.