The FDA has announced that Real Water ceased operations after the non-viral hepatitis outbreak associated with their alkaline water may have sickened at least 16 people. According to a consent decree complaint, the company allegedly failed to comply with FDA manufacturing requirements.
U.S. District Judge Jennifer A. Dorsey entered a consent decree of permanent injunction on June 1, 2021 between the United States and AffinityListstyles.com Inc, which is the majority shareholder of Real Water Inc. According to the compliant filed by the Department of Justice on behalf of the FDA, the defendants allegedly violated the FD&C Act by operating facilities that failed to meet preventive controls requirements to control food hazards.
The complaint also alleges that the products are adulterated within the meaning of the FD&C Act because they were prepared, packed, or held under insanitary conditions “whereby they may have become contaminated with filth or may have been rendered injurious to health.” Finally, the complaint alleges that the products are misbranded because the labels do not declare the common or usual name of each ingredient.
The consumption of Real Water alkaline water was the only known common link between five cases of acute liver failure in children living in Nevada that occurred in November and December 2020. Since then, 11 more cases of acute non-viral hepatitis have been diagnosed in adults. This is an increase of five more cases since the last update on April 26, 2021.
The newest identified cases include one woman in her 60s with underlying medical conditions who tragically died. These adult cases are possibly linked to the consumption of Real Water alkaline water. The newest adult cases are not included in the FDA complaint.
You can contact attorney Fred Pritzker for help by calling 1-888-377-8900 or 612-338-0202.
Noted food safety attorney Fred Pritzker, who has filed many lawsuits, including wrongful death lawsuits, on behalf of clients against manufacturers, store chains, restaurants, and processors, said, “We are glad that the FDA has taken this action. This tragic death and these serious illnesses did not have to occur. No one should suffer because they bought bottled water. Now that Real Water ceased operations, hopefully no one else will get sick.”
The defendants must cease operations until they complete corrective actions, including hiring a qualified independent expert to inspect their facilities. The company did recall their products, but the recall process had issues and the water was found on online retailer sites weeks after the recall was issued.
There are 16 probable illnesses and one suspect illness in this non-viral hepatitis outbreak. All of the patients live in Nevada. The last illness onset date was December 3, 2020.
The FDA is reiterating that it is crucial that consumers, restaurants, distributors, and retailers not drink, cook with, sell, or serve Real Water alkaline water. And this water should not be served to pets.
If you have consumed this water and have been suffering with the symptoms of non-viral hepatitis, which are usually the same as viral hepatitis, including jaundice, fatigue, light colored stools, dark urine, vomiting, and abdominal pain, see your doctor.
If you or a loved one have been sickened with a non-viral hepatitis infection after drinking recalled Real Water alkaline water products, please contact our experienced attorneys for help at 1-888-377-8900 or 612-338-0202.
