ALERT: Infant Ibuprofen Recalled Nationwide

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Infant ibuprofen sold at Walmart, CVS, Family Dollar recalled

MONMOUTH JUNCTION, N.J. — /PRNewswire/ — Monmouth Junction, NJ, Tris Pharma, Inc. has voluntarily recalled three (3) lots of Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL, to the retail level. The recalled lots of the product have been found to potentially have higher concentrations of ibuprofen.

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. 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; sold by Walmart; lots 00717009A (expiration 02/19), 00717015A (expiration 04/19) and 00717024A (expiration 08/19); NDC: 49035-125-23;

CVS Health: Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, 0.5 oz. bottle; sold by CVS Pharmacy; lot 00717024A (expiration 08/19); NDC: 59779-925-23;

Family Wellness: Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, 0.5 oz. bottle; sold by Family Dollar; lot 00717024A (expiration 08/19); NDC: 55319-250-23.

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

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