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Infant Ibuprofen Recalled Over Dosage Problem

New reports indicate that national retailer CVS is recalling liquid baby ibuprofen products after discovering that the dose contained in the medicine could be higher than the label says.

The three recalled packages of Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL may have concentrations of ibuprofen "that are too high and therefore could be dangerous," according to the recall announcement.

The over-the-counter liquid pain reliever and fever reducer is meant for small children between the ages of 6 months and 23 months old. Adverse events from the medication may include nausea, vomiting, upper abdominal pain, diarrhea, gastrointestinal pain, ringing in the ears and headache, and more. Thankfully,  no adverse experiences related to the recalled ibuprofen have been reported, according to Tris Pharma.

Credit: PRNewsfoto/Tris Pharma, Inc.

The New Jersey-based drugmaker says that they are working to make sure that parents nationwide are informed of the recall. Here's the most concerning part: the company also says that there is a possibility that a higher level of ibuprofen could lead to permanent kidney damage in small children. Other possible adverse effects include but are not limited to nausea, vomiting, stomach pain and diarrhea. Children can also suffer from tinnitus, headache and stomach bleeding. If your child has had any of these symptoms, seek emergency medical assistance immediately.

Credit: PRNewsfoto/Tris Pharma, Inc.

The impacted products bear lot numbers 00717009A, 00717015A, 00717024A from Walmart; 00717024A from CVS; and 00717024A from Family Dollar. In addition, the packages are labeled with NDC (National Drug Code) numbers of 49035-125-23 from Walmart, 59779-925-23 from CVS and 55319-250-23 from Family Dollar. The recalled products sold at Walmart had expiration dates of February 2019, April 2019 and August 2019, while those made for CVS and Family Dollar expire in August 2019.

Credit: PRNewsfoto/Tris Pharma, Inc.

Tris Pharma has not made any additional comments about the recall. As of press time the company says it has not received any reports of adverse events related to the recall. If you have the recalled ibuprofen at home, you can return it to your point of purchase for a full refund or simply toss it away. The ibuprofen should not be used. If you have any additional questions or concerns, contact your child’s pediatrician or a trusted health professional.

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