September 20, 2007 — /FDA News/ — The U.S. Food and Drug Administration (FDA) is warning consumers not to consume Baby’s Bliss Gripe Water, apple flavor, with a code of 26952V and expiration date of October 2008 (shown as “10/08” on the label), distributed by MOM Enterprises, Inc., of San Rafael, CA. FDA confirmed through laboratory analysis the presence of cryptosporidium after investigating the illness of a 6-week-old infant in Minnesota who consumed the product. Cryptosporidium is a parasite that can cause intestinal infections.

The most common symptom of infection is watery diarrhea. Other symptoms can include dehydration, weight loss, stomach cramps or pain, fever, nausea, and vomiting. Symptoms generally begin two to ten days after becoming infected with the parasite and generally last one to two weeks. While most people with healthy immune systems will recover without treatment, the infection could be serious or life-threatening for certain individuals. Infants, children, and pregnant women are susceptible to dehydration resulting from diarrhea, which can be life-threatening. Individuals with weakened immune systems are also at risk for a more serious and life-threatening form of illness.

Parents of children who have recently consumed Baby’s Bliss Gripe Water, apple flavor, and have these symptoms should seek immediate medical attention. Parents and caregivers who have given this product to their infants and children should be alert for diarrhea and other signs of Cryptosporidium infection.

Approximately 17,600 bottles of the product were distributed nationwide in retail stores and sold over the Internet between November 2006 and September 2007. A code of 26952V with an expiration date of 10/08 appears on the bottle’s carton. The product is sold in a four-ounce plastic bottle packaged inside of a cardboard carton which is labeled with the following: “Baby’s Bliss. Pediatrician Recommended Gripe Water. Apple Flavor. An herbal supplement used to ease the gas and stomach discomfort often associated with colic, hiccups, and teething. Dietary Supplement. 4 fl. ozs. (120 ml). Ginger Extract. Fennel Extract. Other ingredients: Deionized Water, Vegetable Glycerin, Fructose, Natural apple flavor, Citric acid, Bioflavonoid Extract, and Grapefruit Seed Extract. Distributed by: MOM Enterprises, Inc., San Rafael, CA 94903 USA.” FDA advises consumers to throw away bottles of the product described above that they have in their possession.

MOM Enterprises, Inc. is fully cooperating with FDA’s investigation into the cause of the contamination and is recalling all potentially contaminated products. FDA continues to investigate and will provide updates as more information becomes available. Consumers can call the FDA at 1-888-723-3366.

Web site: www.fda.gov