COMPANY ANNOUNCEMENT

Pseudomonas Aeruginosa Bacteria Found In Saje Splish Splash Gentle Baby Wash

This recall has been completed and FDA has terminated this recall.

When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.

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Summary

Company Announcement Date:: July 06, 2018
FDA Publish Date:: March 24, 2020
Product Type:: Cosmetics
Skin Care Products
Reason for Announcement:: Recall Reason Description

May contain the bacteria Pseudomonas aeruginosa
Company Name:: Saje Natural Wellness
Brand Name:: Brand Name(s)

Saje Natural Wellness
Product Description:: Product Description

Splish Splash Gentle Baby Wash

Company Announcement

Saje Natural Wellness is warning customers not to use Splish Splash Gentle Baby Wash, 8.5 fl. oz. and 1.7 fl. oz. (found in the Wee and Well Gentle Baby Care Kit) as it may contain the bacteria Pseudomonas aeruginosa. Pseudomonas aeruginosais an opportunistic pathogen that causes infection and results in bacteria in the blood, particularly in individuals with compromised immune systems.

The product being recalled is:

Brand Name & Product Name	Product SKU	Package Size	Lot Number	Expiry Date
Saje Natural Wellness Splish Splash Gentle Baby Wash	700552 (USA/Int’l)	8.5 fl. oz.	814020	All expiry dates
Saje Natural Wellness Splish Splash Gentle Baby Wash (found in Wee and Well Gentle Baby Care Kit)	700561 (USA/Int’l)	1.7 fl. oz.	814020	All expiry dates

The product is distributed in the United States through Saje retail locations in California, New Jersey, and New York. The product is also distributed through online sales across the United States and internationally.

Based on routine sample testing, one lot (814020) of Splish Splash Gentle Baby Wash 8.5 fl. oz. was found to contain the bacteria Pseudomonas aeruginosa.

There have not been any reported adverse reactions for this product in the United States to date.

As a precautionary measure, consumers who have received or purchased Splish Splash Gentle Baby Wash (Lot# 814020), in any size or format, should return the product to a Saje retail outlet, for a full refund. The 6 digit lot number is located on the information panel on the back of the product, below the SKU number. Consumers may also contact the Customer Experience team at Saje Natural Wellness to return the product through prepaid mail, and to receive a full refund. Phone 1-877-275-7253 or email hello@saje.com. The hours of operation are from 05:00AM to 08:00PM PST, Monday through Friday and 08:00AM to 05:00PM PST Saturday and Sunday.

Company Contact Information

Consumers:: Customer Experience; 1-877-275-7253; hello@saje.com

Media:: Trevor Ellestad; (604) 561-8356; tellestad@saje.com