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U.S. Department of Health and Human Services


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Recall -- Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

Novartis Nutrition Corporation Issues Nationwide Recall of One Lot of its Diabetisource  AC Product

Brandi Robinson

FOR IMMEDIATE RELEASE -- Minneapolis, MN -- November 16, 2005 -- Novartis Nutrition Corporation is recalling 2,712 bottles of an enteral feeding formula which was incorrectly labeled as Diabetisource® AC 1.5 Liter bottles lot 2135L. The product contained in these bottles is Resource Diabetic® TF a tube feeding formulated for diabetes which contains sodium and calcium caseinate, components of milk. People with an allergy or severe sensitivity to milk run the risk of a serious or life threatening allergic reaction if they consume this product. The recall is being conducted with the knowledge of the FDA.

Healthcare professionals administering to patients who have an allergy or sensitivity to milk should immediately stop using this product. Healthcare institutions that have received shipping cartons labeled Resource Diabetic® TF lot number 2135L or bottles labeled Diabetisource® AC 1.5 Liter bottles lot 2135L should contact Novartis Customer Services at 1-800-333-3785. Consumers who have questions can contact this same 800 number.

In addition the two products are not nutritionally equivalent. The product label for Diabetisource® AC indicates that the 1.5L container provides 1800 calories and 150 grams of carbohydrate. Consuming Resource Diabetic® TF, the patient would receive 1590 calories and 127 grams of carbohydrate in a 1.5L container.

The affected product was shipped nationwide and is only distributed to healthcare institutional facilities. Affected product is not distributed to retail outlets. The recalled bottles were shipped in cartons correctly labeled as Resource Diabetic® TF lot 2135L however the bottles were incorrectly labeled as Diabetisource AC. Lot 2135L.

Novartis Nutrition Corporation has notified its distributors requesting that they stop sale immediately and return all product in their inventory.

Novartis Nutrition Corporation takes its mission of improving the health and well-being of patients in healthcare delivery settings very seriously, and therefore believe it is necessary to take this precautionary action.

The foregoing press release contains certain forward-looking statements that can be identified by terminology such as "would receive," or similar expressions, or by express or implied discussions regarding any potential revenue impact from the recall and labeling issues which are the subject of this release. Such forward-looking statements involve known and unknown risks, uncertainties or other factors that may cause the actual results to be materially different from any future results, performance, or achievements expressed or implied by such statements. In particular, management's expectations could be affected by, among other things, uncertainties relating to the recall process; unexpected additional labeling or other manufacturing difficulties with respect to Resource Diabetic® TF or Diabetisource®; as well as 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.


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