The Food and Drug Administration (FDA) has ordered withdrawal of bottles of Baby's Bliss Gripe Water, fearing they may be contaminated with a parasite that causes severe diarrhea.
The agency said the suspect products are apple flavor and carry the code "26952V" with an expiration date of October 2008 (shown as "10/08") on the label. The products are distributed by MOM Enterprises, Inc., of San Rafael, California.
Gripe water is a home remedy for babies with colic, gas, teething pain or other stomach ailments. Its chief active ingredients vary among commercial preparations, but may include alcohol, bicarbonate, ginger, dill, fennel and sometimes chamomile. It is typically dispensed directly to the infant with a dropper in liquid form.
Adults have also been known to take gripe water for soothing intestinal pains, gas, or other stomach ailments, but in larger doses.
Consumers should dispose of unopened bottles of the product, the FDA said and revealed that it had confirmed the presence of cryptosporidium after investigating the illness of a six-week-old infant in Minnesota who consumed possibly infected Baby Bliss gripe water.
Cryptosporidium is a parasite commonly found in lakes and rivers, especially when the water is contaminated with sewage and animal wastes. Cryptosporidium is very resistant to disinfection, and even a well-operated water treatment system cannot ensure that drinking water will be completely free of this parasite, says the US Environmental Protection Agency (EPA).
The most common symptom of the resulting infection is watery diarrhea. Other symptoms can include dehydration, weight loss, stomach cramps or pain, fever, nausea, and vomiting. Symptoms generally begin two to 10 days after infection 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 infants, children, and pregnant women, who are susceptible to dehydration resulting from diarrhea. Individuals with weakened immune systems are also at risk for a more serious form of illness.
The FDA said that about 17,600 bottles of the product have been distributed nationwide in retail stores and sold over the Internet since November 2006.
The product is sold in four-ounce plastic bottles packaged in a cardboard carton labeled "Baby's Bliss.
The FDA, which said that the distributor is cooperating with the agency in a nationwide recall of the product, is continuing its investigation of the supplement.