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Infant ibuprofen recalled :

December 6, 2018
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Editor's note: An updated version of this story is available at http://www.aappublications.org/news/2019/01/31/ibuprofenrecall013119.

Three lots of infant ibuprofen have been recalled due to potentially high concentrations of the drug.

Tris Pharma Inc. has recalled Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 milligrams per 1.25 milliliters. The medication was sold in 0.5 ounce bottles 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://prn.to/2rmfqTn.

No adverse events have been reported to Tris Pharma Inc., but 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 micc_tris@vigilarebp.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.

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