Drug maker expands recall for infant ibuprofen over dosage concern

Jan. 31 (UPI) -- Pharmaceutical officials are expanding a recall for a generic brand of infant ibuprofen due to concerns it has a higher dose than labeled.

Tris Pharma initially recalled ibuprofen sold under the Walmart, CVS Pharmacy and Family Dollar brands, but has now expanded the warning to other products manufactured for CVS and Walmart. The company said it affects 50-milligram bottles.

No serious adverse effects have been reported, Tris Pharma said in a statement this week.

"The reason for the recall was a potential higher concentration of ibuprofen of less than 10 percent above the specific limit in some bottles from these three batches," it added. "Safety issues or toxicity is generally accepted to be a concern in infants at doses in excess of 700 percent of the recommended dose."

The company said infants already susceptible to adverse effects of ibuprofen are at greater risk with the recalled drugs. A "remote possibility," Tris Pharma said, could be permanent kidney damage in certain infants.

Other adverse effects could include nausea, vomiting, diarrhea, ringing ears, headaches and gastrointestinal bleeding.

The decision to recall the drugs was based on an evaluation by the Food and Drug Administration, officials said.

Tris Pharma said parents unsure if they should throw away medication should contact their physician.