A company statement read there is also a "remote possibility" that infants may experience side effects including nausea, vomiting, stomach pain and diarrhea due to the increased potency.
The company has not received any reports of problems related to the products under recall. "Tinnitus, headache and gastrointestinal bleeding". Tris Pharma did not immediately respond to Newsweek 's request for comment.
The recalled products are sold at Walmart, CVS and Family Dollar stores nationwide.
The Equate ibuprofen packages sold at Walmart have an national drug code of 49035-125-23 and include lot numbers 00717009A with an expiration date of February 2019, 00717015A with an expiration date of April 2019 and 00717024A with an expiration date of August 2019.More news: FL toddler battling cancer in need of extremely rare blood
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According to the label, the ibuprofen - meant to be used as a pain reliever or fever reducer - contained 50 mg per 1.25 mL.
Consumers with questions regarding this recall can contact Tris Customer Service at 732-940-0358 (Monday through Friday, 8:00 a.m. ET- 5:00 p.m. PT) or via email at mailto:firstname.lastname@example.org.
"This recall is being conducted with the knowledge of the U.S. Food and Drug Administration".
They were packaged in 0.5oz bottles for three products Infants' Ibuprofen Concentrated Oral Suspension that were sold by Walmart, CVS, and Family Dollar.