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 recalled lots of the product have been found to potentially have higher concentrations of ibuprofen. It could be potentially risky for babies and could cause nausea, vomiting, epigastric pain or diarrhea. "Tinnitus, headache and gastrointestinal bleeding".
It was not clear from the public statement exactly how or when Tris Pharma discovered the problem, or why it came about.
The affected products were sold at several Walmart, CVS Pharmacy and Family Dollar stores across the country.
CVS offers it under the "CVS Health" label, with the recalled products bearing the NCD number 59779-925-23 and the lot number 00717024A. And in Family Dollar, the recalled lot is 00717024A (expiry 08/19). The company has not received any reports of adverse reactions to the recalled drug.
Wholesalers and retailers have been ordered to stop selling the product and customers with questions are asked to call Tris Customer Service at 732-940-0358.
The brands of infant ibuprofen concentrated oral suspension are Equate from Wal-Mart, CVS Health, and Family Wellness at Family Dollar.
The company said that the recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
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