May 2013 FDA Recall Nicardipine Hydrochloride by West-ward Pharmaceutical Corp. (D-691-2013 - Failed Impurity/Degradation Specifications; out of specification value for impurity Nitrophenylpuridine Derivative (NPP-D))
This Class III drug recall was voluntarily initiated by West-ward Pharmaceutical Corp. on May 13, 2013 for the product Nicardipine Hydrochloride. The FDA reported the reason for recall as failed impurity/degradation specifications; out of specification value for impurity nitrophenylpuridine derivative (npp-d). The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-691-2013
Failed Impurity/Degradation Specifications; out of specification value for impurity Nitrophenylpuridine Derivative (NPP-D)
05-13-2013
07-17-2013
Lot PLNJ1201 -16,880 vials ; Lot PLNJ1202 - 16,960 vials
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
West-ward Pharmaceutical Corp.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
03-17-2015
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# Lot PLNJ1201 APRIL 2014 Lot PLNJ1202 MAY 2014
