Home / Recalls / Sandoz Incorporated / D-1677-2012

D-1677-2012 Class III Terminated

Recalled by Sandoz Incorporated — Broomfield, CO

Recall Details

Product Type
Drugs
Report Date
September 26, 2012
Initiation Date
September 12, 2012
Termination Date
April 10, 2013
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
43,060 x 90 count bottles

Product Description

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,

Reason for Recall

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

Distribution Pattern

Nationwide

Code Information

Lot numbers: BJ3338; BJ3339; BJ 3340; BJ3341; BJ3342; BJ6282; BJ7192; BM8498; BJ7202; BJ7203, Exp 12/12

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