FDA-Drug2016-06-22Class III
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
Par Pharmaceutical
Hazard
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.
Sold states
Nationwide and Puerto Rico.
Affected count
12,535 bottles
Manufactured in
6 Ram Ridge Rd, Chestnut Ridge, NY, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1038-2016Don't want to check this manually?
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