Class III
Terminated
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
- Company
- West-Ward Pharmaceutical Corp.
- Recall Initiated
- May 13, 2013
- Posted
- July 17, 2013
- Recall Number
- D-691-2013
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- Lot PLNJ1201 -16,880 vials ; Lot PLNJ1202 - 16,960 vials
- Firm Location
- Eatontown, NJ, United States
Reason for Recall
Failed Impurity/Degradation Specifications; out of specification value for impurity Nitrophenylpuridine Derivative (NPP-D)
Distribution
Nationwide
Lot / Code Info
Lot PLNJ1201 APRIL 2014 Lot PLNJ1202 MAY 2014
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