A New Jersey-based pharmaceutical company issued a recall of its infants' liquid ibuprofen after discovering higher concentrations of medication the in some packages.
Tris Pharma said it voluntarily recalled three lots of "Infants' Ibuprofen Concentrated Oral Suspension, USP (NSAID)" on Wednesday because it possibly contained higher amounts of ibuprofen than advertised.
"There is a remote possibility that infants, who may be more susceptible to a higher potency level of drug, and therefore may be more vulnerable to permanent NSAID-associated renal injury," the statement said. "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."
"To date, Tris Pharma Inc. has not received any reports of adverse events related to the lots of product that are the subject of this recall," the company added.
The Monmouth Junction, New Jersey-based drug maker said it sold the affected lots "to one customer, which distributed the lots into the U.S. market."
Tris Pharma did not list the distributor's name, but it said it sent out an "urgent recall notice" and is arranging for the return of the recalled product.