Teething Products Recalled

Posted on May 26, 2018 by

0


Publix posted the following Recall on its website.

Orajel Teething Products Product Recall, sold at Publix

Church & Dwight Co. announced the safety of our customers and their children is our highest priority. Based on the May 23, 2018 communication from the U.S. Food and Drug Administration regarding over-the-counter (OTC) teething products containing benzocaine, we are discontinuing the distribution and sale of Orajel teething products containing benzocaine. Orajel teething products containing benzocaine and labeling have complied with applicable and evolving FDA requirements since we acquired the brand in 2008. The discontinuation is effective immediately and includes Orajel Medicated Teething Gel, Orajel Medicated Nighttime Teething Gel, Orajel Medicated Daytime & Nighttime Teething Twin Pack and Orajel Medicated Teething Swabs. We are not discontinuing other Orajel products, which represent the majority of our Orajel offering.

In addition, we are revising the Drug Facts Label on all over-the-counter oral health care products that contain benzocaine with an intended use other than teething to emphasize that these products should not be used for teething pain or in children under 2 years of age. In addition, we are adding warning statements to more clearly identify the risks and symptoms presented by methemoglobinemia, a rare but serious condition associated with the use of benzocaine. For more information, please visit www.fda.gov or call our Consumer Relations hotline at 1-800-952-5080.

Information regarding Orajel products sold at Publix affected by this recall:

Product Name GTIN #
Orajel Medicated Daytime Teething Gel 3-10310-03313-2
Orajel Medicated Nighttime Teething Gel 3-10310-33940-1

Consumers who may have purchased the product listed above should stop usage and return the product to their local store for a full refund. Customers can also contact Orajel Consumer Relations hotline at 1-800-952-5080.


© 2018 US Food Safety Corporation. No copyright claim is made for portions of this blog and linked items that are works of the United States Government, state governments or third parties.

Tagged: ,
Posted in: Family safety