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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
Date:1/8/2012

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
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    SOURCE Novartis Consumer Health, Inc.
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