Tris Pharma, Inc. of New Jersey has issued an expansion of a voluntary nationwide recall of infant Ibuprofen due to concerns that it may contain a higher concentration than labeled.
The items of concern were manufactured for Walmart, CVS Pharmacy, and Family Dollar. No events of serious adverse effects have been reported in relation to the recall. The company said,
“The reason for the recall was a potential higher concentration of Ibuprofen of less than 10% above the specified limit in some bottles from these three batches. Safety issues or toxicity is generally accepted to be a concern in infants at doses in excess of 700% of the recommended dose.”