Sandoz Incorporated recalls Pramipexole Dihydrochloride Tablets, 0.25 mg, 90-count tablets per bottle, Rx only, Manufactured in India by Sandoz Priv
Recalled September 26, 2012 · FDA recall D-1677-2012 · Sandoz Incorporated
Hazard
Impurities/Degradation Products: An out of specification result for a known impurity of the product occurred during 12 month stability testing. · FDA Class III
Units
43,060 x 90 count bottles
Sold at
Nationwide
Description
Impurities/Degradation Products: An out of specification result for a known impurity of the product occurred during 12 month stability testing.
Product
Pramipexole Dihydrochloride Tablets, 0.25 mg, 90-count tablets per bottle, Rx only, Manufactured in India by Sandoz Private Ltd., for Sandoz Inc., Princeton, NJ 08540, NDC 0781- 5249-92,
Manufacturer(s)
Sandoz Incorporated
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →