EWING, N.J.,
Sept. 13,
2023 /PRNewswire/ -- Church & Dwight Co., Inc.
(NYSE: CHD) today initiated a voluntary recall of one specific
lot of ThereaBreath Strawberry Splash for Kids 16oz after the
Company identified a microbial contamination due to the presence of
yeast (Candida Parapsilosis) in lot #PA3083011 of
TheraBreath Strawberry Splash for Kids 16 oz, to the
consumer level and sold exclusively on Amazon
between May 31 and September 02,
2023.
No other TheraBreath products or other lots of TheraBreath
Strawberry Splash for Kids are included in this recall.
The use of the affected product in immune compromised
individuals could potentially result in severe or life-threatening
adverse events such as fungemia or disseminated fungal infection.
In non-immunocompromised individuals who recently underwent oral
surgery or dental procedures resulting in mucosal barrier
disruption (e.g., tooth extraction) the use of the defective
product may result in infectious complications, but in this
population the infections may be less severe and may be more
readily responsive to treatment. We continue to monitor,
investigate, and respond to any consumer inquiries.
TheraBreath Strawberry Splash for Kids is indicated as an
anti-cavity mouthwash for adults and children 6 years of age and
older. The lot of recalled mouthwash product is listed below with
the Universal Product Code (UPC) and Lot number. Church &
Dwight is coordinating closely with the U.S. Food & Drug
Administration (FDA) and following all relevant protocols.
Consumers who have purchased the product listed below should
stop consumption immediately. Please call our Consumer Relations
team at +1 (800) 981-4710 before disposing of the
product, and we will provide a full refund. Any additional
questions can also be directed to our Consumer Relations team
Monday through Friday, 9am –
5pm ET.
Consumers who want to verify if their product is affected by the
issue may do at www.churchdwightrecall.com.
Adverse reactions or quality problems experienced with the use
of this product may be reported to the FDA's MedWatch Adverse Event
Reporting program either online, by regular mail or by fax.
- Complete and submit the report Online:
www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form
www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request
a reporting form, then complete and return to the address on the
pre-addressed form, or submit by fax to 1-800-FDA-0178.
This recall is being conducted with the knowledge of the U.S.
Food and Drug Administration.
RECALLED PRODUCT LIST
Reference to identify affected products via Universal Product
Code (UPC) and Lot Code.
Product
Name
|
TheraBreath Strawberry Splash Kids
16oz
|
Product #
|
20509730
|
Lot #
|
PA3083011
|
UPC #
|
6 97029 70000
6
|
ASIN
|
B0BTDVVTGL
|
Media Contact:
Edelman
ChurchDwightMedia@edelman.com
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SOURCE Church & Dwight Co., Inc.