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

FDA recall notice · announced June 22, 2016 · Par Pharmaceutical

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

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

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.

Notes

Distribution: Nationwide and Puerto Rico.
Lot/code information: Lot #s: 27409201, 27409301, 27409401, Exp. 02/2017; 27662101, Exp. 07/2017
Quantity: 12,535 bottles
Status: Terminated
Products in this recall event:
- 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 (D-1038-2016)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.