Bacteria-infected h2o utilized to marque toothpaste and a mold-like substance were recovered astatine a Tom’s of Maine mill during an inspection earlier this year, according to the Food and Drug Administration.
A warning missive sent to genitor institution Colgate-Palmolive connected Nov. 5 and released connected Tuesday outlined the violations recovered during the May inspection astatine a accumulation installation successful Sanford, Maine.
Three antithetic types of bacteria were recovered successful the h2o astatine the facility, including the h2o that’s utilized to marque Tom’s Simply White cleanable mint toothpaste and Wicked Cool! anticavity toothpaste.
“Batches manufactured aft these incidents were released based connected the microbial investigating of the finished OTC merchandise contempt the prime of the h2o utilized arsenic a constituent oregon to cleanable the equipment,” the FDA said, noting an inspector besides recovered a “black mold-like substance” connected hoses and tanks adjacent different instrumentality utilized for toothpaste production.
“Water is simply a large constituent successful galore of your [over-the-counter] cause products,” the missive reads. “It is indispensable that you employment a h2o strategy that is robustly designed, and that you efficaciously control, support and show the strategy to guarantee it consistently produces h2o suitable for pharmaceutical use.”
The company said successful a statement that it’s cooperating with the FDA to hole the issues and is “fully assured successful the information and prime of” its products.