A recall of infant ibuprofen has been expanded to include three more lots that could have high concentrations of the drug.
Tris Pharma Inc. has voluntarily recalled six lots of Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 milligrams per 1.25 milliliters since December 2018.
The medication was sold in 0.5 ounce and 1-ounce bottles to reduce fever and pain under the Equate, CVS Health and Family Wellness brands at Walmart, CVS and Family Dollar stores, respectively. Additional details on lot numbers and expiration dates are available at https://www.fda.gov/Safety/Recalls/ucm630112.htm.
No adverse events have been reported to Tris Pharma Inc., but ibuprofen concentrations have been found as high as 10% above the specified limit, according to the company. The higher potency could cause nausea, vomiting, diarrhea, tinnitus, headache and gastrointestinal bleeding, according to the company. Infants may be more vulnerable to permanent kidney damage.
Customers with questions can contact Tris at 732-940-0358 or email@example.com. Adverse reactions also can be reported to the Food and Drug Administration’s Medwatch Adverse Event Reporting Program at www.fda.gov/medwatch/report.htm.
The Academy recommends that children under 6 months avoid using ibuprofen unless directed by their doctor.