A recall has been issued for store-brand infants’ ibuprofen sold at Walmart, CVS and Family Dollar locations nationwide, Syracuse reports.
NJ.com reports New Jersey-based pharmaceutical company Tris Pharma announced Wednesday that three lots of its “Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID)” have been found to possibly contain higher amounts of ibuprofen than shown on the label.
Half-ounce bottles of the liquid ibuprofen are supposed to contain 50 mg per 1.25 mL of the pain-reliever/fever-reducer medication.
“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 in a statement.
“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.”
According to ABC , no illnesses or “adverse events” have been reported, but the company issued a voluntary recall out of an abundance of caution.
The affected products were sold at Walmart, CVS and Family Dollar under store-brand names:
* Walmart : Equate: Infants’ Ibuprofen Concentrated Oral Suspension with lot numbers 00717009A, 00717015A, 00717024A with expiration dates of 2/19 and 4/19.
* CVS : Infants’ Ibuprofen Concentrated Oral Suspension with lot number 00717024A and expiration date 8/19.
* Family Dollar : Family Wellness Infants’ Ibuprofen Concentrated Oral Suspension with lot number 00717024A and expiration date 8/19.
According to KOMO , the products were sold to one distributor who sent them to stores across the U.S. Tris Pharma says it is arranging for the products to be returned.
Any consumers who have taken the drugs and/or experienced any problems related to them are advised to contact their physician or healthcare provider.
Additional questions about the recall can be directed to Tris Customer Service at 732-940-0358 (Monday through Friday, 8:00am ET- 5:00pm PT) or via email at firstname.lastname@example.org .