Pramipexole Dihydrochloride Tablets, 0.125 mg, 90-count tablets per bottle, Rx only, Manufactured in India by Sandoz Private Ltd., for Sandoz Inc., Princeton, NJ 08540, NDC 0781-5248-92

Recall Number: D-1678-2012

Firm: Sandoz Incorporated

Classification: Class III

Status: Terminated

Report Date: 20120926

Initiation Date: 20120912

Termination Date: 20130410

Impurities/Degradation Products: An out of specification result for a known impurity of the product occurred during 12 month stability testing.

Pramipexole Dihydrochloride Tablets, 0.125 mg, 90-count tablets per bottle, Rx only, Manufactured in India by Sandoz Private Ltd., for Sandoz Inc., Princeton, NJ 08540, NDC 0781-5248-92