A recall has been issued for infants’ liquid ibuprofen sold by CVS, Family Dollar, and Walmart after it was discovered some packages had higher concentrations of the medication.
Tris Pharma of Monmouth Junction, N.J., announced it recalled three lots of Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL.
“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 said it sold the affected lots “to one customer, which distributed the lots into the U.S. market.”
Tris Pharma did not divulge the distributor’s name, but said it sent out an “urgent recall notice” and is arranging for the return of the recalled product.