Pramipexole dihydrochloride extended release tablets, 0.75 mg, packaged in 30-count bottles, Rx only, Manufactured by: Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC 10370-252-11

Recall Number: D-1185-2018

Firm: Par Pharmaceutical, Inc.

Classification: Class III

Status: Terminated

Report Date: 20180919

Initiation Date: 20180906

Termination Date: 20191206

Failed impurities/degradation specifications: Finished product contain a known product impurity about current specification levels.

Pramipexole dihydrochloride extended release tablets, 0.75 mg, packaged in 30-count bottles, Rx only, Manufactured by: Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC 10370-252-11