Three types of infant’s ibuprofen have been voluntarily recalled by Tris Pharma.
The lots recalled were all “Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID), 50 mg per 1.25 mL,” the company said in a news release.
It said the recall is due to the “remote possibility that infants, who may be more susceptible to a higher potency level of drug … 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,” the news release said.
IT IS EXTREMELY IMPORTANT TO PASS THIS ON! Infant ibuprofen sold at Walmart, CVS and Family Dollar is being recalled because it may have higher levels of ibuprofen than normal. This could cause permanent NSAID-associated renal injury in some infants: https://t.co/MERDvVC2nB
— WSBT (@WSBT) December 6, 2018
While the recall is enough to warn parents away from over-the-counter medication, Tris Pharma was clear that it has not received any reports of the feared adverse events related to the products subject to the recall.
The recalled products are packaged in 0.5-oz bottles and sold at Walmart, CVS and Family Dollar stores. They include the brands Equate, CVS Health and Family Wellness.
Expirations on the affected lots are February 2019 through August 2019.
The impacted products bear lot numbers 00717009A, 00717015A, 00717024A from Walmart; 00717024A from CVS; and 00717024A from Family Dollar.
The packages are labeled with National Drug Code numbers of 49035-125-23 from Walmart, 59779-925-23 from CVS and 55319-250-23 from Family Dollar.
Parents, check your labels! Infant ibuprofen was recalled from Walmart, CVS and Family Dollar for possibly having higher concentrations of ibuprofen. For more info: https://t.co/NCkGzsIdby pic.twitter.com/zXnx50BtCD
— USA TODAY Video (@usatodayvideo) December 6, 2018
The product is used as a general pain reliever and fever reducer in infants and small children.
Tris Pharma said anyone with questions about the recall can call its customer service line at 732-940-0358 or email email@example.com.
Any adverse reactions or quality problems with the products involved in this recall can be reported to the U.S. Food and Drug Administration’s MedWatch program.
Customers also may call 1-800-332-1088 to request a reporting form.
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