FDAFDA · Food and drugs·Recall number D-691-2013
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
Published July 17, 2013 · Recall initiated: May 13, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Impurity/Degradation Specifications; out of specification value for impurity Nitrophenylpuridine Derivative (NPP-D)
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- NICARDIPINE HYDROCHLORIDE
- Manufacturer
- West-ward Pharmaceutical Corp.
- Distributor
- Nationwide
- Lot
- Lot PLNJ1201 APRIL 2014 Lot PLNJ1202 MAY 2014
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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