More than 4.3 million tubes of toothpaste sold under the Brush Buddies, evo and ARU brands are part of a nationwide recall, according to the U.S. Food and Drug Administration. The products include several lines made for children, such as those featuring Barbie, Hot Wheels and My Little Pony.
The FDA rated the recall Class II on Oct. 19, a category for risks that are generally temporary or reversible. Not every tube of the affected products is included, so lot numbers matter.
Pritam International Private Limited began the voluntary recall on Sept. 10, according to CBS12 in West Palm Beach, Florida, and Deseret News. The company is headquartered in India, and Deseret News reported that Ashtel Studios Inc. distributes the products in the U.S.
The stated reason is deviations from Current Good Manufacturing Practice, the set of standards meant to ensure the quality of drug products. Deseret News reported that no specific explanation of what went wrong during manufacturing was given.
Prevention and Deseret News both reported that the recall covers 17 toothpaste products. CBS12 said the FDA Enforcement Report is the source for the recall details.
Based on the lists published by the three outlets, the recall includes:
Lot numbers and expiration dates for each product are in the FDA enforcement report, according to Prevention.
The FDA uses Class II for situations where using or being exposed to a product may cause temporary or medically reversible health effects, or where serious health consequences are considered remote. Deseret News described it as a mid-level risk category. Recalls with a high health risk are placed in Class I.
Prevention reported that the FDA had not announced any injuries or illnesses linked to the recall and had not issued specific guidance for consumers.
Parents of young children are the most likely to be affected, since many of the affected products are sold with popular children’s characters and sweet flavors. Adults who use whitening, sensitive-teeth or gum-health toothpaste from evo or ARU should also look at their tubes.
Deseret News advised consumers to check the lot number on a tube, because only some lots are recalled. A product name alone does not show whether a particular tube is affected.
For tubes that match, Prevention said people should stop using them and either throw them away or return them to the store for a refund. Deseret News said consumers can discard the product or contact the retailer or manufacturer about returns or refunds. Prevention added that anyone who has already used a recalled tube and has health concerns should contact a doctor.
Around Prague, based on reporting by WPEC, Prevention, Deseret News