A pharmaceutical company has issued a recall for three lots of infant ibuprofen distributed to stores nationwide. Tris Pharma, Inc. said Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL, may potentially have higher concentrations of ibuprofen, which could cause renal failure in susceptible infants.
Recalled products were packaged in .5 oz bottles and sold in Walmart, CVS and Family Dollar stores as Equate: Infants’ Ibuprofen Concentrated Oral Suspension, CVS Health: Infants’ Ibuprofen Concentrated Oral Suspension, Family Wellness: Infants’ Ibuprofen Concentrated Oral Suspension.
“Adverse effects that may be experienced are nausea, vomiting, epigastric pain, or more rarely, diarrhea,” a news release said. “Tinnitus, headache and gastrointestinal bleeding are also possible adverse effects.”
The company said it had not received any reports of adverse effects pertaining to the recall, but encouraged those with questions to contact Tris Customer Service at 732-940-0358.
Ibuprofen, is an over-the-counter nonsteroidal anti-inflammatory drug (NSAID) frequently used to relieve pain that is associated with headaches, dental pain, menstrual cramps, muscle aches and arthritis. It is also commonly used to reduce fevers.
The product was sold in Walmart under the “Equate” brand, in CVS under the “CVS Health” brand and in Family Dollar under the “Family Wellness” label.
The company said that the recall is being conducted with the knowledge of the U.S. Food and Drug Administration.