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U.S. Department of Health and Human Services

Enforcement Report - Week of September 26, 2012

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Product Detail

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,
Recall Number D-1677-2012
Classification Class III
Code Info Lot numbers: BJ3338; BJ3339; BJ 3340; BJ3341; BJ3342; BJ6282; BJ7192; BM8498; BJ7202; BJ7203, Exp 12/12
Product Distributed Qty 43,060 x 90 count bottles
Reason For Recall Impurities/Degradation Products: An out of specification result for a known impurity of the product occurred during 12 month stability testing.

Event Detail

Event Id 63160
Product Type Drugs
Status Ongoing
Recalling Firm Sandoz Incorporated
City Broomfield
State CO
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-09-12
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide