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Infant ibuprofen recalled over potency concern

A New Jersey-based pharmaceutical company has issued a voluntary nationwide recall on an infant ibuprofen product distributed to Walmart, CVS Pharmacy and Family Dollar retail stores. The product was found to have potentially higer levels of ibuprofen than what is listed on the box, according to a news release Dec. 5, 2018.

Tris Pharma is recalling three lots of Infants' Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL. The pain reliever and fever reducer was packaged in 0.5 ounce bottles.

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Consumers with questions regarding the recall are directed to Tris Customer Service at 732-940-0358, available during weekday business hours 8 a.m. EST to 5 p.m. PT, Monday through Friday, or via email at micc_tris@vigilarebp.com.

The news release recommends consumers contact their physician or health care provider if they have experienced any problems that may be related to taking or using this drug product.

According to the news release:

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.