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Infant Ibuprofen Drops Recalled for High Drug Concentrations


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The drug manufacturer Tris-Pharma issued a recall of additional batches of infants’ ibuprofen drops this past week. This marks the second over-the-counter pain reliever recall that has been issued by this company since November. A press release issued by the U.S. Food and Drug Administration (FDA) on Jan. 30 outlines how tests have shown that the recalled batches of the infant Ibuprofen likely contain higher than normal drug concentrations.

Infant Ibuprofen Contained 10% More Ibuprofen

Tris-Pharma apparently discovered that certain batches of their medications contained 10 percent more of the ibuprofen than was stated on the package while performing routine testing on it after it had already been released on the market. A standard saturation level for these infants’ ibuprofen drops is 50 mg of the drug per 1.25 ml of the liquid syrup.

Researchers have previously uncovered how ibuprofen can be unsafe or toxic to infants when it’s administered an amount 700 times the recommended dose.

A statement released by the drug manufacturer noted that children who receive unreasonably high amounts of ibuprofen run a greater risk of experiencing vomiting, headaches, diarrhea, nausea, kidney damage and stomach bleeding.

According to the FDA, infants who are given the recalled medication are only at a small risk of experiencing adverse side effects from taking it. A statement issued just this week by a spokesperson at Tris-Pharma notes that they haven’t received any reports of injury related to this recall as of yet.

Generic Infant Ibuprofen Drops Recalled

The batches of the medication that have most recently been recalled include Walmart’s Equate, Family Dollar’s Family Wellness and CVS’s CVS Health Infants’ Ibuprofen drops. The recalled products span a variety of National Drug Code (NDC) and lot numbers.

When consumers hear about dangerous drugs that have been recalled because they injured or killed someone; it often involves prescribed medications. The truth is that there are many over-the-counter drugs that end up causing individuals adverse side effects as well. An attorney can evaluate your case to see if you qualify for compensation for medical costs associated with your health decline.

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