Par Pharmaceutical recalls Pramipexole Dihydrochloride Extended Release Tablets, 0.375 mg, Rx Only, 30 count bottles, Manufactured By: Par Pharmac…

Recall date

May 28, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-1038-2016

FDA classification

Class III

Brand / firm

Par Pharmaceutical

Sold / distributed

Nationwide and Puerto Rico.

Why it was recalled

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.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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