The New Jersey pharmaceutical company Tris Pharma, Inc. has issued a recall on three lots of infant ibuprofen over fears it might contain a higher dosage than is stated on the product, the company said in a Thursday press release.
The recall will affect the medication under the name Infants’ Ibuprofen Concentrated Oral Suspension, which is sold at Walmart, CVS, and Family Dollar and packaged under the private-label brands of the three retailers, according to CBS News. Infant ibuprofen should contain just 50 mg of ibuprofen per 1.25 mL.
“There is a remote possibility that infants, who may be more susceptible to a higher potency level of drug…may be more vulnerable to permanent NSAID-associated renal injury,” the release said, referencing the non-steroidal anti-inflammatory drug. “Adverse effects that may be experienced are nausea, vomiting, epigastric pain or, more rarely, diarrhea. Tinnitus, headache and gastrointestinal bleeding are also possible adverse effects.”
Tris Pharma hasn’t received reports of adverse reactions associated with the recalled medicine. The company sent the lots of affected ibuprofen to one distributor, and has notified them to arrange for the products’ return.
At Walmart, the recalled lots are 00717009A (expires 02/19), 00717015A (expires 04/19) and 00717024A (expires 08/19). At CVS, the recalled lot is 00717024A (expires 08/19). And at Family Dollar, the recalled lot is 00717024A (expires 08/19).
Consumers are encouraged to call a physician or health care provider if there are any issues after using the product, Tris Pharma said.