Three lots of Infants' Ibuprofen Concentrated Oral Suspension, USP (NSAID) have been recalled by Tris Pharma, Inc., due to potentially higher concentrations of ibuprofen found in the product.
Used as a pain reliever and fever reducer, the recalled products were packed in 0.5-ounce bottles and sold by Wal-Mart stores, CVS and Family Dollar, according to a news release.
A list of the recalled lots, as well as their expiration dates and descriptions can be found here.
There is a possibility that infants who may be more susceptible to a higher potency level of the drug may be more vulnerable to permanent NSAID-associated renal injury, the news release said.
"Adverse effects that may be experienced are nausea, vomiting, epigastric pain, or more rarely, diarrhea," Tris Pharma said. "Tinnitus, headache and gastrointestinal bleeding are also possible adverse effects."
Tris Pharma said it has not received any reports of adverse events associated with the medication under recall.
Consumers with questions about the recall can contact the Tris Pharma at 732-940-0358 or via email. Anyone who has experienced problems that may be related to the recalled products is encouraged to contact their health care provider.