Mirapex (pramipexole dihydrochloride) Tablets, 1 mg, 100-count unit-dose tablets per folding carton, Rx only, Distributed by: Boehringer Ingelheim (BI) Pharmaceuticals, Inc., Ridgefield, CT 06877 USA, Made in Germany, NDC 0597-0190-61.

Recall Number: D-0991-2019

Firm: Boehringer Ingelheim Pharmaceuticals, Inc.

Classification: Class III

Status: Terminated

Report Date: 20190320

Initiation Date: 20190307

Termination Date: 20190911

Failed Tablet/Capsule Specifications: identification of low weight tablets during routine stability testing.

Mirapex (pramipexole dihydrochloride) Tablets, 1 mg, 100-count unit-dose tablets per folding carton, Rx only, Distributed by: Boehringer Ingelheim (BI) Pharmaceuticals, Inc., Ridgefield, CT 06877 USA, Made in Germany, NDC 0597-0190-61.