Product: 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
Reason for recall: Impurities/Degradation Products: An out of specification result for a known impurity of the product occurred during 12 month stability testing.
Recall initiated: 20120912
Status: Terminated
Classification: Class III
Recall type: Voluntary: Firm initiated