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      Novartis Consumer Health Inc. Issues Voluntary Nationwide Recall of Certain Over-the-Counter Products Due to Potential Presence of Foreign Tablets or Chipped or Broken Tablets or Gelcaps


      News provided by

      Novartis Consumer Health, Inc.

      Jan 08, 2012, 12:12 ET

      Share this article

      Share this article


      PARSIPPANY, N.J., Jan. 8, 2012 /PRNewswire/ -- Novartis Consumer Health, Inc. (NCH) announced today that it is voluntarily recalling all lots of select bottle packaging configurations of Excedrin® and NoDoz® products with expiry dates of December 20, 2014 or earlier as well as Bufferin® and Gas-X Prevention® products with expiry dates of December 20, 2013 or earlier, in the United States. NCH is taking this action as a precautionary measure because the products may contain stray tablets, capsules, or caplets from other Novartis products, or contain broken or chipped tablets.

      The affected bottle sizes are attached to this release. The Novartis Consumer Health Inc. Lincoln, NE facility has voluntarily suspended operations and shipments to accelerate maintenance and other improvement activities at the site.

      This recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA).

      Mixing of different products in the same bottle could result in consumers taking the incorrect product and receiving a higher or lower strength than intended or receiving an unintended ingredient. This could potentially result in overdose, interaction with other medications a consumer may be taking, or an allergic reaction if the consumer is allergic to the unintended ingredient. NCH is not aware of adverse events reported with the issues leading to the recall.

      These over-the-counter products were distributed nationwide to wholesalers and retailers.

      Novartis Consumer Health Inc. is notifying its distributors and customers and is arranging for return of all recalled products. Wholesalers and retailers should stop distribution and return the affected product using Novartis Product Return information that is being provided to them.

      Consumers that have the product(s) being recalled should stop using the product(s) and contact the Novartis Consumer Relationship Center at 1-888-477-2403 (available Monday-Friday 9 a.m. to 8 p.m. Eastern Time) for information on how to return the affected products and receive a full refund. For more detailed information, consumers should visit our website at www.novartisOTC.com as of January 9, 2012. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these drug products.

      Adverse events that may be related to the use of these products may be reported to FDA's MedWatch Adverse Event Reporting Program either online, by regular mail or by fax:

      • Online: www.fda.gov/medwatch/report.htm
      • Regular Mail: use postage-paid FDA form 3500 available at:
        www.fda.gov/MedWatch/getforms.htm.
        Mail to MedWatch, FDA, 5600 Fishers Lane, Rockville, MD  20852-9787
      • Fax: 1-800-FDA-0178

      These actions announced today, highlight the strong Novartis commitment to a single quality standard for the Novartis Group. The Novartis Group is making the necessary investments and committing the right resources to ensure these are implemented across the entire Novartis Group network. The high quality of Novartis products and operations has been critical to building the Novartis Group reputation over the past 15 years. Novartis Group is committed to ensuring the highest standard for patients who rely on our products and medicines.

      Novartis Consumer Health Inc. plans to gradually resume operations at its Lincoln, NE site following implementation of planned improvements and in agreement with the FDA. The Novartis Consumer Health Inc. Lincoln, NE facility produces a variety of products mainly for the US market with annual sales value of less than 2% of Novartis Group sales. At this stage, it is not possible to determine when the plant will resume full operations and the full financial impact of these events. NCH will take a one-time charge currently estimated at USD 120 million in the fourth quarter of 2011, relating to the recalls and improvement work at the Lincoln, NE facility.

      Novartis commitment to quality

      The Novartis Group is fully committed to ensuring the quality, safety and integrity of its products. All Novartis Group companies have a clear commitment to patients and Health Authorities to ensure high quality standards for all our products and services. Novartis Group companies stand behind the safety and efficacy of their products, and are fully committed to maintaining high quality standards at all production sites in the US and around the world. All Novartis Group products are subjected to strict manufacturing, testing and monitoring standards. Where they fall outside the standards, Novartis Group companies take actions to correct the issue and may recall products as a precaution.

      Disclaimer

      The foregoing release contains forward-looking statements that can be identified by terminology such as "potential," "will," "committed," "commitment," "plans," or similar expressions, or by express or implied discussions regarding the potential length of the shutdown of our Lincoln, NE production facility, regarding the potential for any further regulatory actions at the Lincoln, NE production facility, regarding the potential for any further quality issues arising at any additional Novartis manufacturing facilities, or regarding the potential financial impact of the Lincoln, NE facility shutdown. You should not place undue reliance on these statements.  Such forward-looking statements reflect the current views of management regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that our Lincoln, NE production facility will reopen at any particular time. Nor can there be any guarantee that actions described in this release will be the only regulatory actions required at the Lincoln, NE facility.  Neither can there be any guarantee that further quality issues will not arise at any additional Novartis Group manufacturing facilities.  Nor can there be any guarantee as to the potential financial impact on Novartis resulting from the shutdown of the Lincoln, NE production facility. In particular, management's expectations could be affected by, among other things, unexpected regulatory actions or delays or government regulation generally; unexpected manufacturing issues, including unexpected inabilities to satisfy regulators' requirements for the reopening of the Lincoln, NE production facility; competition in general; government, industry and general public pricing pressures; the impact that the foregoing factors could have on the values attributed to the Novartis Group's assets and liabilities as recorded in the Group's consolidated balance sheet, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

      About Novartis

      Novartis Group provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, eye care, cost-saving generic pharmaceuticals, preventive vaccines and diagnostic tools, over-the-counter and animal health products. Novartis is the only global company with leading positions in these areas. In 2010, the Group's continuing operations achieved net sales of USD 50.6 billion, while approximately USD 9.1 billion (USD 8.1 billion excluding impairment and amortization charges) was invested in R&D throughout the Group. Novartis Group companies employ approximately 121,000 full-time-equivalent associates and operate in more than 140 countries around the world. For more information, please visit http://www.novartis.com.

      Novartis is on Twitter. Sign up to follow @Novartis at http://twitter.com/novartis.

      Novartis Media Relations

       

       

      Julie Masow

      Novartis Corporation

      +1 212 830 2465 (direct)

      +1 862 579 8456 (mobile)

      [email protected]

       

      Pamela McKinlay

      Novartis Consumer Health, Inc.

      +1 973 503 7337(direct)

      +1 862 221 0151(mobile)

      [email protected]

       

      e-mail: [email protected]

      Milicent Brooks

      Novartis Consumer Health, Inc.

      +1 973 503 7483(direct)

      +1 973 479 2078 (mobile)

      [email protected]

       

      For Novartis multimedia content, please visit www.thenewsmarket.com/Novartis
      For questions about the site or required registration, please contact: [email protected].

      Material

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      UPC Code

      UCC Code

      NDC Code

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      300672043917

      10300672043914

      0067203991

       

      100008086

      Excedrin® Migraine Caplets 100CT New Label

      300672039910

      10300672039917

      0067203991

       

      100008443

      Excedrin® Migraine Caplets 125CT Bonus Pack No Carton

      300672039842

      10300672039849

      0067203984

       

      100008461

      Excedrin® Migraine Caplets 125CT Bonus Pack New Carton

      300672039866

      10300672039863

      0067203986

       

      100007215

      Excedrin® Migraine Caplets 125CT Bonus Pack

      300672039835

      10300672039832

      0067203983

       

      100008090

      Excedrin® Migraine Caplets 200CT New Label

      300672039927

      10300672039924

      0067203992

       

      100009016

      Excedrin® Migraine Caplets 24+6CT Bonus Pack

      300672039309

      10300672039306

      0067203930

       

      100003182

      Excedrin® Migraine Caplets 24CT

      300672039248

      10300672039245

      0067203924

       

      100008084

      Excedrin® Migraine Caplets 24CT New Label

      300672039248

      10300672039245

      0067203924

       

      100008809

      Excedrin® Migraine Caplets 250+50CT Bonus Pack

      300672039576

      10300672039573

      0067203955

       

      100004174

      Excedrin® Migraine Caplets 250CT No Carton

      300672039071

      10300672039078

      0067203907

       

      100008093

      Excedrin® Migraine Caplets 250CT No Carton New Label

      300672039071

      10300672039078

      0067203907

       

      100004870

      Excedrin® Migraine Caplets 250CT Special Inners

      300672039774

      10300672039771

      0067203977

       

      100008091

      Excedrin® Migraine Caplets 250CT New Label

      300672039774

      10300672039771

      0067203977

       

      100003121

      Excedrin® Migraine Caplets 300CT

      300672039330

      10300672039337

      0067203933

       

      100007469

      Excedrin® Migraine Caplets 300CT New Carton

      300672039330

      10300672039313

      0067203933

       

      100008092

      Excedrin® Migraine Caplets 300CT New Label

      300672039330

      10300672039313

      0067203933

       

      100008471

      Excedrin® Migraine Caplets 300CT Club Tray

      300672039330

      10300672039313

      0067203933

       

      100008085

      Excedrin® Migraine Caplets 50CT New Label

      300672039507

      10300672039504

      0067203950

       

      100003185

      Excedrin® Migraine Caplets 50CT 

      300672039507

      10300672039504

      0067203950

       

      100008079

      Excedrin® Migraine Caplets 8CT New Label

      300672039088

      10300672039085

      0067203908

       

      100008015

      Excedrin® Migraine Gel  Tablets 160CT

      300672035165

      10300672035162

      0067203516

       

      100004681

      Excedrin® Migraine Gel Tablets 100CT Special Inner

      300672035912

      10300672035919

      0067203591

       

      100008096

      Excedrin® Migraine Gel Tablets 100CT New Label

      300672035912

      10300672035919

      0067203591

       

      100008657

      Excedrin® Migraine Gel Tablets 100CT Account Specific

      300672044914

      10300672044911

      0067203591

       

      100008094

      Excedrin® Migraine Gel Tablets 24CT - New Label

      300672035240

      10300672035247

      0067203524

       

      100008819

      Excedrin® Migraine Gel Tablets 2X50CT

      300672035936

      10300672035933

      0067203593

       

      100008095

      Excedrin® Migraine Gel Tablets 50CT New Label

      300672035509

      10300672035506

      0067203550

       

      100004675

      Excedrin® Migraine Tablets 100CT Special Inner

      300672037916

      10300672037913

      0067203791

       

      100008082

      Excedrin® Migraine Tablets 100CT New Label

      300672037916

      10300672037913

      0067203791

       

      100008437

      Excedrin® Migraine Tablets 125CT Bonus Pack

      300672037831

      10300672037838

      0067203783

       

      100009094

      Excedrin® Migraine Tablets 24+6CT Bonus Pack

      300672037305

      10300672037302

      0067203730

       

      100003174

      Excedrin® Migraine Tablets 24CT

      300672037244

      10300672037241

      0067203724

       

      100008080

      Excedrin® Migraine Tablets 24CT New Label

      300672037244

      10300672037241

      0067203724

       

      100004872

      Excedrin® Migraine Tablets 250CT Special Inner

      300672037770

      10300672037777

      0067203777

       

      100008083

      Excedrin® Migraine Tablets 250CT New Label

      300672037770

      10300672037777

      0067203777

       

      100003173

      Excedrin® Migraine Tablets 50CT

      300672037503

      10300672037500

      0067203750

       

      100008081

      Excedrin® Migraine Tablets 50CT New Label

      300672037503

      10300672037500

      0067203750

       

      100008049

      Excedrin® PM Caplets 100CT New Label

      300672055910

      10300672055917

      0067205591

       

      100008459

      Excedrin® PM Caplets 125CT Bonus Pack New Carton

      300672055866

      10300672055863

      0067205586

       

      100008047

      Excedrin® PM Caplets 24CT New Label

      300672055248

      10300672055245

      0067205524

       

      100008048

      Excedrin® PM Caplets 50CT New Label

      300672055507

      10300672055504

      0067205550

       

      100007146

      Excedrin® PM Express Gel Caplets 20CT 

      300676405209

      10300676405206

      0067640520

       

      100008632

      Excedrin® PM Express Gel Caplets 80CT Account Specific

      300676405810

      10300676405817

      0067640580

       

      100007202

      Excedrin® PM Express Gel Caplets 80CT No Carton

      300676409801

      10300676409808

      0067640980

       

      100007148

      Excedrin® PM Express Gel Caplets 80CT New Label

      300676405803

      10300676405800

      0067640580

       

      100008629

      Excedrin® PM Tablets 100CT Account Specific

      300672053923

      10300672053920

      0067205391

       

      100008065

      Excedrin® PM Tablets 100CT Account Specific No Carton

      300672053947

      10300672053944

      0067205394

       

      100008064

      Excedrin® PM Tablets 100CT New Label

      300672053916

      10300672053913

      0067205391

       

      100008449

      Excedrin® PM Tablets 125CT Bonus Pack

      300672053831

      10300672053838

      0067205383

       

      100009095

      Excedrin® PM Tablets 24+6CT Bonus Pack

      300672053305

      10300672053302

      0067205330

       

      100008051

      Excedrin® PM Tablets 24CT New Label

      300672053244

      10300672053241

      0067205324

       

      100008063

      Excedrin® PM Tablets 50CT New Label

      300672053503

      10300672053500

      0067205350

       

      100008046

      Excedrin® PM Tablets 8CT New Label

      300672053084

      10300672053081

      0067205308

       

      100008040

      Excedrin® Sinus Headache Caplets 24CT New Label

      300672062246

      10300672062243

      0067206224

       

      100004691

      Excedrin® Tension Headache Caplets 100CT Special Inner

      300672045911

      10300672045918

      0067204591

       

      100006001

      Excedrin® Tension Headache Caplets 100CT Account Specific No Carton

      300672045942

      10300672045949

      0067204594

       

      100008057

      Excedrin® Tension Headache Caplets 100CT Account Specific No Carton New Label

      300672045942

      10300672045949

      0067204594

       

      100008628

      Excedrin® Tension Headache Caplets 100CT Account Specific 

      300672045959

      10300672045956

      0067204591

       

      100008056

      Excedrin® Tension Headache Caplets 100CT New Label

      300672045911

      10300672045918

      0067204591

       

      100008442

      Excedrin® Tension Headache Caplets 125CT Bonus Pack

      300672045836

      10300672045833

      0067204583

       

      100008453

      Excedrin® Tension Headache Caplets 125CT Bonus Pack No Carton

      300672045843

      10300672045840

      0067204584

       

      100009007

      Excedrin® Tension Headache Caplets 24+6CT Bonus Pack

      300672045300

      10300672045307

      0067204530

       

      100004689

      Excedrin® Tension Headache Caplets 24CT Special Inner

      300672045249

      10300672045246

      0067204524

       

      100008068

      Excedrin® Tension Headache Caplets 24CT New Label

      300672045249

      10300672045246

      0067204524

       

      100003209

      Excedrin® Tension Headache Caplets 250CT

      300672045775

      10300672045772

      0067204577

       

      100004406

      Excedrin® Tension Headache Caplets 250CT No Carton

      300672045072

      10300672045079

      0067204507

       

      100004690

      Excedrin® Tension Headache Caplets 50CT Special Inner

      300672045508

      10300672045505

      0067204550

       

      100008069

      Excedrin® Tension Headache Caplets 50CT New Label

      300672045508

      10300672045505

      0067204550

       

      100007978

      Excedrin® Tension Headache Express Gel Caplets 20CT 

      300676272207

      10300676272204

      0067627220

       

      100007979

      Excedrin® Tension Headache Express Gel Caplets 40CT 

      300676272405

      10300676272402

      0067627240

       

      100007981

      Excedrin® Tension Headache Express Gel Caplets 80CT Account Specific 

      300676272948

      10300676272945

      0067627294

       

      100007980

      Excedrin® Tension Headache Express Gel Caplets 80CT 

      300676272801

      10300676272808

      0067627280

       

      100008060

      Excedrin® Tension Headache Gel Tablets 24CT New Label

      300672050243

      10300672050240

      0067205024

       

      100007153

      Gas-X® Prevention® Caplets 20CT

      300433005208

      10300433005205

      N/A

       

      100007154

      Gas-X® Prevention® Caplets 50CT

      300433005505

      10300433005502

      N/A

       

      100004719

      NoDoz® Maximum Strength Caplets 16CT

      300672070166

      10300672070163

      0067207016

       

      100008716

      NoDoz® Maximum Strength Caplets 16CT New Graphic

      300672070166

      10300672070163

      0067207016

       

      100004720

      NoDoz® Maximum Strength Caplets 36CT

      300672070364

      10300672070361

      0067207036

       

      100008715

      NoDoz® Maximum Strength Caplets 36CT New Graphic

      300672070364

      10300672070361

      0067207036

       

      100004721

      NoDoz® Maximum Strength Caplets 60CT

      300672070609

      10300672070606

      0067207060

       

      100008717

      NoDoz® Maximum Strength Caplets 60CT New Graphic

      300672070609

      10300672070606

      0067207060

       

      SOURCE Novartis Consumer Health, Inc.

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