drugs Class III Updated 2012-09-26

Sandoz Incorporated recalls Pramipexole Dihydrochloride Tablets, 0.125 mg, 90-count tabl

Recalled 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

Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot numbers: KW10J511, KW10J512, KW10J513, KW10J514, KW10J515, BJ3167, BJ3172, BJ3177, BJ3179, BJ3188, BJ3182. Exp. 09/12
View official government recall

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