Infant Ibuprofen Recall
Tris Pharma has recalled three lots of infant ibuprofen because of high levels of ibuprofen that could cause renal injury as well as other adverse symptoms. This photo taken on October 20, 2018 shows Panei Mon, wife of jailed journalist Wa Lone, cradling their two-month-old baby girl Thet Htar Angel in their Yangon apartment before leaving for a visit in Insein prison. - Myanmar Reuters journalists Wa Lone and Kyaw Soe Oo have been sentenced to seven years in jail under a state secrets act but observers say their trial was simply punishment for daring to investigate atrocities committed by the military against the country's persecuted Rohingya Muslim minority. Getty Images/Phyo Hein KYAW

Tris Pharma, Inc. has recalled three lots of its infant ibuprofen which is sold under the Equate, CVS Health, and Family Wellness brands at Walmart, CVS, and Family Dollar stores.

The recalled product includes Infant’s Ibuprofen Concentrated Oral Suspension, USP(NSAID 50 mg per 1.25 L, which was found to have potentially high concentrations of ibuprofen. The recalled medication is used as a pain reliever and fever reducer and was packaged in 0.5 oz bottles.

The recalled lots include 00717009A , 00717015A , and 00717024A with expiration dates of 02/19, 04/19, and 08/19, respectively. Tris Pharma is urging retailers and wholesalers to stop selling the affected ibuprofen.

According to the company, there is the remote possibility that infants that take the medication may be more vulnerable to renal injury. Infants that are susceptible to the high levels of ibuprofen may experience nausea, vomiting, and epigastric pain. In some case, diarrhea, tinnitus, headache, and gastrointestinal bleeding may also occur.

Consumers that experience any issues with taking the recalled infant ibuprofen should contact their healthcare provider.

Consumers with questions about the recalled medication should contact Tris Pharma customer service at 732-940-0358, from 8 a.m. EST to 5 p.m. PT, Monday through Friday. Emails can be sent to micc_tris@vigilarebp.com.

Consumers may also report any adverse reactions from the recalled medication to the FDA’s MedWatch Adverse Event Reporting program by submitting a form online at www.fda.gov/medwatch/report.htm. Forms can also be downloaded from www.fda.gov/MedWatch/getforms.htm and mailed to the address provided or faxed to 1-800-332-1088.

The company said it has not received any reports of adverse effects from the recalled ibuprofen. It has arranged for the return of the affected medication by the sole customer that distributed it to the U.S. market.

Tris Pharma had made the recall in cooperation with the U.S. Food and Drug Administration.

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