New Jersey-based Tris Pharma, Inc. is voluntarily recalling three lots of liquid infant ibuprofen that might be more concentrated than advertised.
The recall covers Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 ml.
Tris Pharma says the medication was sold under Walmart, CVS Pharmacy and Family Dollar brands.
"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 company said. "Adverse effects that may be experienced are nausea, vomiting, epigastric pain, or more rarely, diarrhea. Tinnitus, headache and gastrointestinal bleeding."
Below is information on each of the recalled product’s labels.
To date, Tris Pharma has not received any reports of adverse events related to the recall.
Anyone with questions regarding this recall can contact Tris Customer Service at 732-940-0358 or via email at Customer Service Email .