MONMOUTH JUNCTION, NJ - Three lots of infants' ibuprofen concentrated oral suspension USP 50mg per 1.25ML have been recalled to due potential higher concentrations of ibuprofen, announced Tris Pharma Inc.

The recalled products have been found to potentially have higher concentrations of ibuprofen, the company said in a press release. The product is used as a pain reliever/fever reducer and was packaged in 0.5 oz. bottles. 

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, said the company. Adverse effects may include nausea, vomiting, epigastric pain, or more rarely, diarrhea. Tinnitus, headache and gastrointestinal bleeding are also possible adverse effects., they said.

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The products were sold in Walmart, CVS and Family Dollar stores with the following information.

NDC; LOT; EXPIRATION; DESCRIPTION ; COMPANY;
49035-125-23 00717009A
00717015A
00717024A
02/19
04/19
08/19
Equate: Infants’ Ibuprofen Concentrated Oral Suspension,
USP (NSAID), 50 mg per 1.25 mL,
0.5 oz. bottle
Wal-Mart Stores Inc
59779-925-23 00717024A 08/19 CVS Health: Infants’ Ibuprofen Concentrated Oral Suspension,
USP (NSAID), 50 mg per 1.25 mL,
0.5 oz. bottle
CVS Pharmacy
55319-250-23 00717024A 08/19 Family Wellness: Infants’ Ibuprofen Concentrated Oral Suspension,
USP (NSAID), 50 mg per 1.25 mL,
0.5 oz. bottle
Family Dollar Services Inc

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. Consumers with questions regarding this recall can contact Tris Customer Service at 732-940-0358 (Monday through Friday, 8:00am ET- 5:00pm PT)