Pramipexole Dihydrochloride Tablets, 0.125 mg, 90-count tablets per bottle, Rx only, Manufactured...
FDA Recall #D-1678-2012 — Class III — September 12, 2012
Product Description
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.
Recalling Firm
Sandoz Incorporated — Broomfield, CO
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
41,761bottles.
Distribution
Nationwide
Code Information
Lot numbers: KW10J511, KW10J512, KW10J513, KW10J514, KW10J515, BJ3167, BJ3172, BJ3177, BJ3179, BJ3188, BJ3182. Exp. 09/12
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated