D-1038-2016 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- June 22, 2016
- Initiation Date
- May 28, 2016
- Termination Date
- March 3, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12,535 bottles
Product Description
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
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.
Distribution Pattern
Nationwide and Puerto Rico.
Code Information
Lot #s: 27409201, 27409301, 27409401, Exp. 02/2017; 27662101, Exp. 07/2017