Monmouth Junction-based Tris Pharma Inc. has voluntarily recalled three lots of Infants’ Ibuprofen Concentrated Oral Suspension, 50 milligrams. The recalled lots of the product have been found to potentially have higher concentrations of ibuprofen.
The product is used as a pain reliever/fever reducer and was packaged in half-ounce bottles
According to the U.S. Food and Drug Administration, there is a remote possibility that infants may be more susceptible to a higher potency level of the drug and therefore may be more vulnerable to permanent nonsteroidal anti-inflammatory drugs (NSAID)-associated renal injury.
Adverse effects may include nausea, vomiting, epigastric pain or, more rarely, diarrhea. Tinnitus, headache and gastrointestinal bleeding are also possible effects.
To date, according to the FDA, Tris has not received any reports of adverse events related to the lots of product that are the subject of this recall.
Consumers with questions regarding the recall can contact Tris Customer Service weekdays from 8 a.m.-8 p.m. at 732-940-0358.