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Infant ibuprofen recall expanded due to higher concentrations of the drug

Posted at 10:20 PM, Jan 30, 2019

Tris Pharma announced this week it has expanded the scope of a November 2018 recall to include Ibuprofen Oral Suspension Drops, as some units from these batches have been found to have higher levels of Ibuprofen concentration.

According to the recall, some of the recalled products have been found to contain Ibuprofen as high as 10 percent above the specified limit.

The products are sold at CVS and Walmart stores, as well as other retailers.

The recall states that some infants who may be more susceptible to a higher potency level of drug may be more vulnerable to permanent NSAID-associated renal injury.

The recall says that nausea, vomiting, epigastric pain, or more rarely, diarrhea are possible adverse effects. Tinnitus, headache and gastrointestinal bleeding are also possible adverse effects, the recall says.

The product is used as a pain reliever/fever reducer and was packaged in 0.5 oz. and 1 oz. bottles.

For more information on the recalled products, click here .