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Upsher-Smith Laboratories Announces Expansion of Voluntary Nationwide Recall  
2/22/2011 6:41:44 AM

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:

Product

Batch Number

Expiration Date

Product Identification

Amantadine 100 mg (100-ct bottles)

284166

Aug-12

Peach; imprinted AMT, 832

Amantadine 100 mg (100-ct bottles)

280603

Jul-12

Peach; imprinted AMT, 832

Amantadine 100 mg (100-ct bottles)

283797

Jul-12

Peach; imprinted AMT, 832





Amlodipine 5 mg (90-ct bottles)

280564

May-12

White; scored; imprinted ALP, 5, 832

Amlodipine 5 mg (90-ct bottles)

282661

Aug-12

White; scored; imprinted ALP, 5, 832





Androxy 10 mg (100-ct bottles)

283336

Sep-12

Green; scored; imprinted 86, 832





Baclofen 10 mg (90-ct bottles)

284651

Sep-12

White; scored; imprinted BAC, 10, 832

Baclofen 10 mg (90-ct bottles)

282346

Aug-12

White; scored; imprinted BAC, 10, 832

Baclofen 10 mg (100-ct bottles)

281664

Aug-12

White; scored; imprinted BAC, 10, 832





Bethanechol 5 mg (100-ct bottles)

282255

Aug-12

White; scored; imprinted BCL, 5, 832

Bethanechol 10 mg (100-ct bottles)

280569

Jun-12

White; scored; imprinted BCL, 10, 832

Bethanechol 25 mg (100-ct bottles)

280567

Jun-12

Yellow; scored; imprinted BCL, 25, 832





Jantoven 1 mg (100-ct bottles)

280617

Mar-12

Pink; scored; imprinted WRF, 1, 832

Jantoven 1 mg (100-ct bottles)

282872

Jul-12

Pink; scored; imprinted WRF, 1, 832

Jantoven 2 mg (100-ct bottles)

280598

Jun-12

Lavender; scored; imprinted WRF, 2, 832

Jantoven 2.5 mg (100-ct bottles)

281667

Jul-12

Green; scored; imprinted WRF, 2 ½, 832

Jantoven 3 mg (100-ct bottles)

280612

Jun-12

Tan; scored; imprinted WRF, 3, 832

Jantoven 3 mg (100-ct bottles)

284081

Sep-12

Tan; scored; imprinted WRF, 3, 832

Jantoven 4 mg (100-ct bottles)

283334

Jul-12

Blue; scored; imprinted WRF, 4, 832

Jantoven 5 mg (100-ct bottles)

280581

Jun-12

Peach; scored; imprinted WRF, 5, 832

Jantoven 5 mg (100-ct bottles)

283340

Jul-12

Peach; scored; imprinted WRF, 5, 832

Jantoven 5 mg (100-ct bottles)

283459

Sep-12

Peach; scored; imprinted WRF, 5, 832

Jantoven 5 mg (100-ct bottles)

283455

Jun-12

Peach; scored; imprinted WRF, 5, 832

Jantoven 6 mg (100-ct bottles)

282277

Jun-12