Nicardipine Hydrochloride Injection Recalled for Out-of-Specification Organic Impurities
Eugia US LLC is recalling Nicardipine Hydrochloride Injection nationwide due to failed impurity specifications. The 335,940 affected vials contain organic impurities exceeding acceptable standards.
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: FDA Class II recall of a prescription cardiac injectable with out-of-specification organic impurities. This qualifies as a risk-of-harm pharmaceutical product; although no illness or injury has been reported, improper pharmaceutical formulation could affect drug efficacy or patient safety.
Plain-English summary
Eugia US LLC is recalling Nicardipine Hydrochloride Injection (2.5mg/mL in 10mL vials), distributed by AuroMedics Pharma LLC, due to failed impurity and degradation specifications. Approximately 335,940 vials have been distributed nationwide within the United States.
The affected lot numbers are: 3NC23002 (expiration July 2024), 3NC22013, 3NC22014, 3NC22015, 3NC22016, 3NC22017, 3NC22018 (expiration February 2024), and 3NC22020 (expiration March 2024). The recalled product contains organic impurities that are out of specification.
No illnesses or adverse events have been reported to date. Healthcare providers and pharmacies should stop dispensing the affected lots immediately. Patients taking this medication should contact their healthcare provider before making any changes to their treatment regimen. To arrange product return or replacement, contact AuroMedics Pharma LLC or Eugia US LLC.
The recalled product
- Product
- NICARDIPINE HYDROCHLORIDE (NICARDIPINE HYDROCHLORIDE)
- Brand
- NICARDIPINE HYDROCHLORIDE
- Manufacturer
- Eugia US LLC
- Category
- Drug — Injectable / Cardiac
- Hazard
- organic-impurity
- degradation
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 (11)
- Lot #: 3NC23002
- Exp. Date 7/24
- 3NC22013
- 3NC22014
- 3NC22015
- 3NC22016
- 3NC22017
- 3NC22018
- Exp. Date 2/24
- 3NC22020
- Exp. Date 3/24
UPCs (1)
- 0355150183012
Distribution
Distributed nationwide across the United States.
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