Nicardipine Hydrochloride Injection recall
FDA recall D-0391-2024 · initiated Feb 20, 2024
Eugia US LLC recalled Nicardipine Hydrochloride Injection in Feb 2024 — an FDA Class II recall (D-0391-2024) because Failed Impurities/Degradation Specifications: Out of specification for organic impurities.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Failed Impurities/Degradation Specifications: Out of specification for organic impurities
An impurity above the accepted limit
A by-product of manufacturing or storage exceeded the limit the FDA accepts. Nitrosamines are the common example: the concern is long-term exposure, not immediate danger from one dose.
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: 43,920 vials
Details
- Product
- Nicardipine Hydrochloride Injection, USP 25mg/mL (2.5 mg/mL) 10 mL vials, Distributed by: AuroMedics Pharma LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520, NDC 55150-183-11
- Recalling company
- Eugia Pharma
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide within the United States
- Initiated
- Feb 20, 2024
- FDA report date
- Mar 27, 2024
Frequently asked
- Was Nicardipine Hydrochloride Injection recalled?
- Eugia US LLC recalled Nicardipine Hydrochloride Injection in Feb 2024 — an FDA Class II recall (D-0391-2024) because Failed Impurities/Degradation Specifications: Out of specification for organic impurities. 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-0391-2024 was: Failed Impurities/Degradation Specifications: Out of specification for organic impurities
- 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: Nationwide within the United States. The recall covers these lots — Lot #: 3NC22019, Exp. Date 2/24. 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-0391-2024.