May 2016 FDA Recall Drug by Par Pharmaceutical
D-1038-2016 - Failed Impurities/Degradation Specifications

This Class III drug recall was voluntarily initiated by Par Pharmaceutical on May 28, 2016 for the product Drug. The FDA reported the reason for recall as failed impurities/degradation specifications. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1038-2016

Reason for Recall
Failed Impurities/Degradation Specifications: Par Pharmaceutical is recalling Pramipexole Dihydrochloride Extended Release tablets because it contains a known product impurity above currently approved specification levels.
Initiated
05-28-2016
Reported
06-22-2016
Quantity
12,535 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74270
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Par Pharmaceutical
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide and Puerto Rico.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-03-2017
Product Description About Product Description
Full technical description of the product.
Pramipexole Dihydrochloride Extended Release Tablets, 0.375 mg, Rx Only, 30 count bottles, Manufactured By: Par Pharmaceutical Companies, Inc., Chestnut Ridge, NY 10977, NDC 10370-251-11

Batch or Lot Expiration Information

Lot# s: 27409201, 27409301, 27409401, Exp. 02/2017; 27662101, Exp. 07/2017