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Upsher-Smith Laboratories Announces Expansion of Voluntary Nationwide Recall
Date:2/18/2011

MAPLE GROVE, Minn., Feb. 18, 2011 /PRNewswire/ -- Upsher-Smith Laboratories, Inc., of Maple Grove, Minnesota is voluntarily expanding its previously announced recall of Jantoven® Warfarin Sodium, USP, 3 mg Tablets to include additional products that were packaged on the same packaging line between May 17, 2010 and November 17, 2010.  The company is initiating the recall as a precautionary measure after a single bottle labeled as Jantoven® Warfarin Sodium, USP, 3 mg Tablets was found by a retail pharmacy to contain tablets at a higher, 10 mg strength.

At Upsher-Smith, patient safety is of foremost concern.  The substitution of warfarin, or any other product, may lead to a change in the therapeutic effect of the intended drug.Consistent, continuous dosing of any product is necessary for optimal care for many ill patients.  Patients should check with their health care provider regarding the appropriateness of their current therapy prior to making any change.  

The expanded recall includes the following products:ProductBatch NumberExpiration DateProduct IdentificationAmantadine 100 mg (100-ct bottles)

284166

Aug-12

Peach; imprinted AMT, 832Amantadine 100 mg (100-ct bottles)

280603

Jul-12

Peach; imprinted AMT, 832Amantadine 100 mg (100-ct bottles)

283797

Jul-12

Peach; imprinted AMT, 832Amlodipine 5 mg (90-ct bottles)

280564

May-12

White; scored; imprinted ALP, 5, 832Amlodipine 5 mg (90-ct bottles)

282661

Aug-12

White; scored; imprinted ALP, 5, 832Androxy 10 mg (100-ct bottles)

283336

Sep-12

Green; scored; imprinted 86, 832Baclofen 10 mg (90-ct bottles)

284651

Sep-12

White; scored; imprinted BAC, 10, 832Baclofen 10 mg (90-ct bottles)

282346

Aug-12

White; scored; imprinted BAC, 10, 832Baclofen 10 mg (100-ct bottles)

281664

Aug-12

White; scor
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SOURCE Upsher-Smith Laboratories, Inc.
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