Nicardipine Hydrochloride Injection Recalled for Sterility Assurance Concerns
American Regent, Inc. is recalling Nicardipine Hydrochloride Injection (25 mg/10 mL) in one lot due to lack of assurance of sterility. The recall affects approximately 4,136 cartons distributed in Utah.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall without reported illnesses or hospitalizations; precautionary recall due to sterility assurance concerns without confirmed contamination, fitting the 'voluntary precautionary recalls' criterion at severity score 2.
Plain-English summary
American Regent, Inc. is recalling Nicardipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL) due to lack of assurance of sterility. The affected product is lot number 23087N0C0 with expiration date 11/2024 (NDC 72572-470-10). Approximately 4,136 cartons, each containing 10 single-dose vials, were distributed in Utah.
The recalled product was manufactured by American Regent, Inc., New Albany, OH for Civica, Inc., Lehi, UT. Nicardipine Hydrochloride Injection is an intravenous medication prescribed for blood pressure management.
Persons who have received this medication should contact their healthcare provider with questions about their current medication. Healthcare facilities should identify and quarantine remaining product with lot number 23087N0C0.
This recall was initiated by American Regent, Inc. at the request of the FDA. For more information about this recall, contact the FDA Drug Safety office or the recalling manufacturer.
The recalled product
- Product
- NICARDIPINE HYDROCHLORIDE (NICARDIPINE HYDROCHLORIDE)
- Brand
- NICARDIPINE HYDROCHLORIDE
- Manufacturer
- American Regent, Inc.
- Category
- Drug — Cardiovascular Injection
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 23087N0C0
- Exp. Date 11/2024
Distribution
Distributed in 1 state:
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