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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.

Natural Organics, Inc. Issues Allergy Alert on Undeclared Casein in Bottles and Sample Packets of "Nature's Plus Animal Parade Children's Chewable Calcium, Natural Vanilla Sundae Flavor"

Contact:
Natural Organics, Inc.
1-800-645-9500

FOR IMMEDIATE RELEASE -- Melville, NY -- December 2, 2004 -- Natural Organics Inc. of Melville, NY is recalling certain lots of 90-count bottles of "Nature's Plus Animal Parade Children's Chewable Calcium, Natural Vanilla Sundae Flavor" (Product Nos. 29996, E2999601, E2999602), and 2-count sample packets of "Nature's Plus Animal Parade Children's Chewable Calcium, Natural Vanilla Sundae Flavor" (Product No. 79996), because they may contain trace amounts of undeclared casein, a milk derivative, therefore posing a potential health hazard to individuals with milk allergies or severe sensitivity to milk.

The product was distributed nationwide to retail stores and to the following foreign countries: United Kingdom, Northern Ireland, Republic of Ireland, France, Russia, South Korea, Indonesia, Singapore, Japan, Philippines, Netherlands, Germany, Spain, Italy, Switzerland, Honduras, Trinidad, Jamaica, and United Arab Emirates.

The product is a white chewable tablet in various animal shapes contained in a 90-count amber plastic bottle bearing a lot number printed on the bottom of the bottle, or in sample packets containing 2 chewable tablets. The following bottled lot numbers are affected: 1021176, 1026101, 1027564,1031816, 1034956, 1036178, 1037365, 1040904, 1042758, 1044825, 1047386, 1047393, 1047525, 1048517,1050151, 1050154, 1051997,1053348, 1053973, 1054445, 1057193, 1057397, 1057707, 1060047, 1060499, 1060500,1060806, 1061489, 1061901, 1061981, 1063812, 1064562, 1064940, 1065113, 1066328, 1066447, 1069110, 1070316, 1073315, 1074734, 1075490, 1076653, 1070724, 1077869, 1079306, 1081876, 1082099.

The following sample packet lot numbers are affected: 03703A, 1037089, 14204A, 19703C, 27203A, 32103A, A31902.

One allergic reaction has been reported to date. Please note that other than the presence of casein, this product is safe and may be consumed by individuals who are not allergic to milk.

The recall was initiated after it was discovered that the casein-containing product was distributed in packaging that did not reveal the presence of milk. Subsequent investigation indicates the problem was caused by a natural vanilla flavor raw material that contained trace amounts of casein, a milk derivative. The product labeling has been corrected.

Consumers who have purchased the affected 90-count bottles of "Nature's Plus Animal Parade Children's Chewable Calcium, Natural Vanilla Sundae Flavor " and/or have been given the 2-count Sample packets of "Nature's Plus Animal Parade Children's Chewable Calcium, Natural Vanilla Sundae Flavor" are advised to return them to the place of purchase. Consumers with questions may contact the company at 1-800-645-9500.

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