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U.S. Department of Health and Human Services

Enforcement Report - Week of July 17, 2013

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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