Nicardipine Hydrochloride Injection
FDA Recall NDC 0143-9634
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Nicardipine Hydrochloride (NDC 0143-9634). A significant event, classified as Class III, was initiated on May 13, 2013 by Hikma Pharmaceuticals Usa Inc.. The reported reason for this action was: "Failed Impurity/Degradation Specifications; out of specification value for impurity Nitrophenylpuridine Derivative (NPP-D)"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
May 2013 Class III Recall: Failed Impurity/Degradation Specifications; out of specification value for impurity Nitrophenylpuridine Derivative (NPP-D)
Recall Number
Class III Terminated
Failed Impurity/Degradation Specifications; out of specification value for impurity Nitrophenylpuridine Derivative (NPP-D)
May 13, 2013
Jul 17, 2013
Lot PLNJ1201 -16,880 vials ; Lot PLNJ1202 - 16,960 vials
Recall Profile & Regulatory Data
Event ID
65287
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
West-ward Pharmaceutical Corp.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Mar 17, 2015
Product Description
Nicardipine Hydrochloride Injection 25 mg/10 mL (2.5 mg/mL), 10 mL single-use vials, Rx Only, Mfd. by Exela Pharma Sciences, LLC, Lenoir, NC, Dist. by: West-ward Pharmaceutical Corp., Eatontown, NJ --- NDC 0143-9689-10
Batch or Lot Expiration Information
Lot# Lot PLNJ1201 APRIL 2014 Lot PLNJ1202 MAY 2014
Affected Packages Involved in this Recall
0143-9689-01Product
0143-9689-10Product
0143-9633-01Product
0143-9633-10Product
0143-9634-01Product
0143-9634-10Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
