drugs Class III Updated 2012-09-26

Sandoz Incorporated recalls Pramipexole Dihydrochloride Tablets, 0.25 mg, 90-count table

Recalled 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,

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: BJ3338; BJ3339; BJ 3340; BJ3341; BJ3342; BJ6282; BJ7192; BM8498; BJ7202; BJ7203, Exp 12/12
View official government recall

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