Nicardipine Hydrochloride Injection Recalled Due to Out-of-Specification Organic Impurities
Eugia US LLC is recalling 43,920 vials of Nicardipine Hydrochloride Injection nationwide due to failure to meet organic impurity specifications. No illnesses have been reported.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II drug recall for out-of-specification organic impurities in an injectable prescription medication. While no illnesses or injuries have been reported, the product poses a potential risk of harm to patients who receive the affected vials, meeting the criterion for Score 3 (risk-of-harm without reported injury).
Plain-English summary
Nicardipine Hydrochloride Injection, USP 25 mg/mL in 10 mL vials is being recalled by Eugia US LLC. The recall affects Lot #3NC22019 (expiration date 2/24), which comprises 43,920 vials distributed nationwide.
The product was recalled because it failed to meet U.S. Pharmacopeial Convention (USP) specifications for organic impurities. The vials contain organic impurity levels that exceed acceptable limits established by the FDA.
This injectable drug was distributed nationwide to healthcare facilities. Hospitals, pharmacies, and healthcare providers who have received this product should stop using it and consult with their healthcare provider about alternative medications. Patients who have received this medication should contact their healthcare provider to discuss their treatment.
No illnesses or injuries related to this product have been reported to the FDA.
The recalled product
- Product
- NICARDIPINE HYDROCHLORIDE (NICARDIPINE HYDROCHLORIDE)
- Brand
- NICARDIPINE HYDROCHLORIDE
- Manufacturer
- Eugia US LLC
- Category
- Drug
- Hazard
- organic-impurity
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 #: 3NC22019
- Exp. Date 2/24
UPCs (2)
- 0355150183111
- 0355150183029
Distribution
Distributed nationwide across the United States.
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