The FDA has released the following:
MaryRuth’s, a leading omni-channel health and wellness brand that offers vitamins, minerals, and supplements for the entire family, today announced that, out of an abundance of caution, it is voluntarily recalling two lots of its liquid probiotic for infants (1oz) due to the possibility of contamination by Pseudomonas aeruginosa. Pseudomonas aeruginosa is a microorganism found in the environment that, if ingested, can cause infection in immunocompromised individuals or, rarely, in very young infants. P. aeruginosa infections in immunocompromised infants are generally limited to hospital settings. In such settings, there is the chance that the infant’s immature gut will not be able to prevent P. aeruginosa from gaining access to the blood, and from there it can disseminate elsewhere in the body, resulting in the possibility of serious adverse health consequences.
This recall only affects two lots of the product, Lot #100420218 and Lot #100520218, UPC barcode number 856645008587. Lot numbers are located on the side of the bottle and on the bottom of the outer container in which the product is sold. No other lots or any other MaryRuth’s products are affected by this recall. This product is distributed nationwide through Target, Amazon, and direct sales from the company’s website.
The company is asking consumers to throw away product from both affected lot numbers. Impacted consumers may contact MaryRuth’s Customer Care Center to request a full refund, please see contact information provided below.
The company discovered the potential issue with one of its manufacturing partners during routine laboratory testing, which is a part of MaryRuth’s vigorous quality assurance procedures and safety protocols, and decided to take this precautionary measure. The only product complaint the company has received with respect to the affected product lots was one report of temporary diarrhea in an older infant after consuming the product, which the company does not believe was related to the presence of the microorganism.
“We apologize for any concern or inconvenience this situation causes our customers and are here to support them,” said MaryRuth’s Founder and CEO MaryRuth Ghiyam. “MaryRuth’s is dedicated to the safety, health and welfare of its customers above all else, and has invested heavily, and continues to invest, in safety and quality protocols to ensure we produce only the best products.”
For more information please contact MaryRuth’s via phone 1-800-210-0813 or email email@example.com. The hours of operation are from 8:00AM to 6:00PM PST every day. More information is available at our website www.maryruthorganics.com/pages/infant-probiotic-voluntary-recall.