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

November 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.

Source: Novartis