Drug recall D-691-2013
Product
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
Reason for recall
Failed Impurity/Degradation Specifications; out of specification value for impurity Nitrophenylpuridine Derivative (NPP-D)
Lots and codes
Lot PLNJ1201 APRIL 2014 Lot PLNJ1202 MAY 2014
Recall details
- Recalling firm
- West-ward Pharmaceutical Corp., Eatontown, NJ
- Quantity
- Lot PLNJ1201 -16,880 vials ; Lot PLNJ1202 - 16,960 vials
- Distribution
- Nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- May 13, 2013
- Terminated
- March 17, 2015
Related products
- Nicardipine Hydrochloride – drug information
- NDC 0143-9633 Nicardipine Hydrochloride · Nicardipine Hydrochloride .2 mg/mL · Hikma Pharmaceuticals USA Inc.
- NDC 0143-9689 Nicardipine Hydrochloride · Nicardipine Hydrochloride 25 mg/10mL · Hikma Pharmaceuticals USA Inc.
- NDC 0143-9634 Nicardipine Hydrochloride · Nicardipine Hydrochloride .1 mg/mL · Hikma Pharmaceuticals USA Inc.