Class III
Terminated
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
This recall has been terminated (originally issued June 22, 2016).
- Company
- Par Pharmaceutical
- Recall Initiated
- May 28, 2016
- Posted
- June 22, 2016
- Recall Number
- D-1038-2016
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 12,535 bottles
- Firm Location
- Chestnut Ridge, NY, United States
- Official Source
- View on FDA website ↗
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
Nationwide and Puerto Rico.
Lot / Code Info
Lot #s: 27409201, 27409301, 27409401, Exp. 02/2017; 27662101, Exp. 07/2017
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