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Tris Pharma, Inc. has voluntarily recalled three lots of Infants' Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL, due to potentially higher concentrations of ibuprofen. The medicines were sold at Walmart, CVS and Family Dollar stores.

"There is a remote possibility that infants, who may be more susceptible to a higher potency level of the drug, and therefore may be more vulnerable to permanent NSAID-associated renal injury," a statement from the company reads. 

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. To date, Tris Pharma, Inc. has not received any reports of adverse events related to the lots of product that are the subject of this recall.

The product is used as a pain reliever/fever reducer and was packaged in 0.5 oz. bottles for the recalled lots listed below:

Equate: Infants'  Ibuprofen Concentrated Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, 0.5 oz. bottle with the following coding — NDC: 49035-125-23, lot numbers 00717009A, 00717015A, 00717024A.

CVS Health: Infants' Ibuprofen Concentrated Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, 0.5 oz. bottle with the following coding — NDC 59779-925-23, lot number 00717024A.

Family Wellness: Infants' Ibuprofen Concentrated Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, 0.5 oz. bottle with the following coding — NDC 55319-250-23, lot number 00717024A.

Consumers with questions regarding this recall can contact Tris Customer Service at 732-940-0358 ( a.m.- 5 p.m. PT) Mondays through Fridays, or via email micc_tris@vigilarebp.com. They should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

For more information, visit https://www.fda.gov/Safety/Recalls/default.htm

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