September 2018 FDA Recall Drug by Par Pharmaceutical, Inc.
D-1185-2018 - Failed impurities/degradation specifications

This Class III drug recall was voluntarily initiated by Par Pharmaceutical, Inc. on September 6, 2018 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-1185-2018

Reason for Recall
Failed impurities/degradation specifications: Finished product contain a known product impurity about current specification levels.
Initiated
09-06-2018
Reported
09-19-2018
Quantity
16,207 (bottles of 30 tablets)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80969
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, Inc.
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.
United States nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-06-2019
Product Description About Product Description
Full technical description of the product.
Pramipexole dihydrochloride extended release tablets, 0.75 mg, packaged in 30-count bottles, Rx only, Manufactured by: Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC 10370-252-11

Batch or Lot Expiration Information

Lot# : 29906202, Exp 12/18; 29993102, Exp 2/19; 30366102, 30373103, Exp 4/19; 31940601, Exp 3/20.