FDA Recalls Nicardipine Hydrochloride Injection Due to Particulate Matter
American Regent, Inc. is recalling 43,460 vials of Nicardipine Hydrochloride Injection due to the presence of particulate matter, including hair, glass, and paraformaldehyde.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the presence of glass and particulate matter in an intravenous injection poses a significant risk of serious injury, meeting the criteria for a Severe rating.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for Nicardipine Hydrochloride Injection, USP, 25 mg/10mL (2.5 mg/mL). The recall involves 43,460 vials manufactured by American Regent, Inc. for Civica, Inc. The affected product is identified by Lot # 25295N0C0 and has an expiration date of 04/30/2027. The product is available in 10 mL Single Dose Vials (NDC 72572-470-01) and 10x10 mL Single Dose Vials (NDC 72572-470-10).
The recall was initiated because the product was found to be contaminated with particulate matter. The specific contaminants identified include hair, glass, and/or paraformaldehyde. This product is distributed nationwide within the United States.
Healthcare providers and patients should discontinue use of the affected lot and contact their pharmacist or the recalling firm for further instructions. This is a prescription-only medication intended for intravenous use.
The recalled product
- Product
- NICARDIPINE HYDROCHLORIDE (NICARDIPINE HYDROCHLORIDE)
- Brand
- NICARDIPINE HYDROCHLORIDE
- Manufacturer
- American Regent, Inc.
- Category
- Drug — Injection
- Affected units
- 43,460
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 #: 25295N0C0
- Exp. Date: 04/30/2027.
Distribution
Distributed nationwide across the United States.
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