Product Detail

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

Recall Number D-691-2013

Classification Class III

Code Info Lot PLNJ1201 APRIL 2014 Lot PLNJ1202 MAY 2014

Product Distributed Qty Lot PLNJ1201 -16,880 vials ; Lot PLNJ1202 - 16,960 vials

Reason For Recall Failed Impurity/Degradation Specifications; out of specification value for impurity Nitrophenylpuridine Derivative (NPP-D)

Event Detail

Event Id 65287

Product Type Drugs

Status Ongoing

Recalling Firm
West-ward Pharmaceutical Corp.
City Eatontown

State NJ
Country US

Voluntary / Mandated Voluntary: Firm Initiated

Recall Initiation Date 2013-05-13

Initial Firm Notification of Consignee or Public Letter

Distribution Pattern Nationwide