Recall of a Batch of Baby's Bliss Gripe Water, Apple flavor from US markets

September 22, 2007, the US Food and drug Administration, the American's equivalent to the Saudi Food and Drug Authority (SFDA), announced a recall of Baby's Bliss Gripe Water, apple flavor, with a code of 26952V and expiration date of October 2008 (10/08) is being recalled from the US market due to the presence of Cryptosporidium infection.

FDA is investigating the illness of a 6-week old infant who consumed the product. The most common symptom of Cryptosporidium infection is watery diarrhea. Other symptoms 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. The infection could be life-threatening for certain individuals, including infants, children, and individuals with weakened immune systems.

Action that Public should follow:

· SFDA advises parents/caregivers of children who have recently consumed Baby's Bliss Gripe Water, apple flavor, and have these symptoms to 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.

· SFDA advises consumers to stop using this product and throw away bottles of the product immediately.

· Check batch number and expiry date prior to purchasing any Baby's Bliss Gripe Water, apple flavor. Ask for help from the pharmacist.

Report Adverse Drug Reactions to the Saudi FDA:

The public and health professionals are encouraged to report adverse drug reactions to the National Pharmacovigilance Center on the Internet at :