- Company Announcement Date:
- March 21, 2022
- FDA Publish Date:
- March 23, 2022
- Product Type:
Skin Care Products
- Reason for Announcement:
Recall Reason Description
Presence of Pluralibacter gergoviae, a bacterium
- Company Name:
- Kao USA Inc.
- Brand Name:
- Product Description:
Ultra Healing Moisturizer
In the news release, Kao USA Conducts Voluntary Recall of Jergens® Ultra Healing Moisturizer, issued 11-Mar-2022 by Kao USA Inc. over PR Newswire, we are advised by the company that in the IDENTIFYING THE AFFECTED PRODUCTS section, two lot codes have been added to the 3 oz size section (“ZU722861” and “ZU722871”). The complete, corrected release follows:
CINCINNATI, Ohio, March 11, 2022 /PRNewswire/ — Kao USA Inc. is asking consumers to check their Jergens® Ultra Healing Moisturizer 3 oz and 10 oz products to determine if it is part of a voluntary recall of the product.
Select units of Jergens® Ultra Healing Moisturizer could show the presence of Pluralibacter gergoviae, a bacterium which typically poses little medical risk to healthy people. However, people who have certain health problems such as weakened immune systems may be more susceptible to infections. Kao USA is urging consumers to discontinue use of the recalled lotion specified below as a precautionary measure.
Further investigation to determine the scope of the issue is still ongoing. However, Kao USA Inc. promptly took the precautionary step of issuing a voluntary recall of the affected product by removing the product in question from warehouses, working with retailers to ensure the product is removed from store shelves, and proactively notifying consumers.
Kao USA cares about our consumers’ safety. We are committed to manufacturing products that not only meet, but exceed, the highest industry standards.
The amount of recalled product is limited to two sizes offered for Jergens® Ultra Healing Moisturizer.
Only specific lots of the 3 oz and 10 oz sizes are affected.
IDENTIFYING THE AFFECTED PRODUCTS
- Jergens® Ultra Healing Moisturizer, manufactured between October 1, 2021 and October 18, 2021, could be impacted.
- The affected lot codes for the 3 oz size can be found on the back of the bottle printed in black ink and begin with the prefix “ZU”:
- The affected lot codes for the 10 oz size can be found on the bottom of the bottle printed in black ink and begin with the prefix “ZU”:
Kao USA Inc. has informed regulatory authorities of the issue and we are working with our partners on improved cleaning and sanitization practices so that similar issues can be prevented in the future.
Anyone who has product from a recalled lot should call the Kao USA Inc. Consumer Care Center for a free product coupon at the following number: 1.800.742.8798 or send an email to: [email protected]. (Hours of operation: Monday – Friday, 9AM – 5PM US ET) A postage paid label and plastic bag will be sent to consumers via mail to easily return the product.
Any adverse events with the use of this product should be reported via the FDA’s MedWatch Program by one of the following methods:
By phone at 888.463.6332
The FDA Safety Information and Adverse Event Reporting Program
US Food and Drug Administration
Center for Drug Evaluation and Research
5600 Fishers Lane, Rockville MD 20857-0001
On the MedWatch Web site at: http://www.fda.gov/medwatch/
Another option is to report any adverse events with the use of this product to Kao USA Inc. Consumer Care Center at the following number: 1.800.742.8798 or email us at [email protected].
Kao USA Inc. is a leading manufacturer of premium beauty care brands that are recognized around the world for
Link to Initial Press Release