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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; scored; imprinted BAC, 10, 832Bethanechol 5 mg (100-ct bottles)

282255

Aug-12

White; scored; imprinted BCL, 5, 832Bethanechol 10 mg (100-ct bottles)

280569

Jun-12

White; scored; imprinted BCL, 10, 832Bethanechol 25 mg (100-ct bottles)

280567

Jun-12

Yellow; scored; imprinted BCL, 25, 832Jantoven 1 mg (100-ct bottles)

280617

Mar-12

Pink; scored; imprinted WRF, 1, 832Jantoven 1 mg (100-ct bottles)

282872

Jul-12

Pink; scored; imprinted WRF, 1, 832Jantoven 2 mg (100-ct bottles)

280598

Jun-12

Lavender; scored; imprinted WRF, 2, 832Jantoven 2.5 mg (100-ct bottles)

281667

Jul-12

Green; scored; imprinted WRF, 2 ½, 832Jantoven 3 mg (100-ct bottles)

280612

Jun-12

Tan; scored; imprinted WRF, 3, 832Jantoven 3 mg (100-ct bottles)

284081

Sep-12

Tan; scored; imprinted WRF, 3, 832Jantoven 4 mg (100-ct bottles)

283334

Jul-12

Blue; scored; imprinted WRF, 4, 832Jantoven 5 mg (100-ct bottles)

280581

Jun-12

Peach; scored; imprinted WRF, 5, 832Jantoven 5 mg (100-ct bottles)

283340

Jul-12

Peach; scored; imprinted WRF, 5, 832Jantoven 5 mg (100-ct bottles)

283459

Sep-12

Peach; scored; imprinted WRF, 5, 832Jantoven 5 mg (100-ct bottles)

283455

Jun-12

Peach; scored; imprinted WRF, 5, 832Jantoven 6 mg (100-ct bottles)

282277

Jun-12

Teal; scored; imprinted WRF, 6, 832Jantoven 6 mg (100-ct bottles)

284079

Sep-12

Teal; scored; imprinted WRF, 6, 832Jantoven 7.5 mg (100-ct bottles)

280614

Aug-12

Yellow; scored; imprinted WRF, 7 ½,

832Jantoven 10 mg (100-ct bottles)

283342

Aug-12

White; scored; imprinted WRF, 10, 832Jantoven 10 mg (100-ct bottles)

282917

Feb-12

White; scored; imprinted WRF, 10, 832Oxybutynin 5 mg (100-ct bottles)

283368

Jul-13

White; scored; imprinted 38, 832Upsher-Smith Laboratories is working cooperatively with the U.S. Food and Drug Administration to implement a nationwide recall as quickly and efficiently as possible.

The products affected were distributed to wholesalers, retail chains and independent pharmacies throughout the United States. The company is notifying its pharmacy customers and wholesalers, and arranging for the return of all recalled products.  These products were packaged at the Upsher-Smith plant in Plymouth, Minnesota.

Consumers and pharmacists can call 1-877-492-4791 for more information and to access product details, Monday-Friday between 8:00 a.m. and 5:00 p.m. (EST).

Any adverse reactions may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Online:

www.fda.gov/MedWatch/report.htmRegular:

Use postage-paid, pre addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm.  Mail to address on the pre-addressed form.Fax:

1-800-FDA-0178About Upsher-SmithUpsher-Smith Laboratories, Inc., founded in 1919, is a privately held pharmaceutical company that develops, manufactures and markets prescription and over-the-counter products.  Upsher-Smith's product portfolio focuses in the areas of women's health, dermatology, cardiology, and CNS diseases. Upsher-Smith is headquartered in Maple Grove, Minn. For more information, visit www.upsher-smith.com.


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