Infant ibuprofen sold at several national retailers has been recalled over concerns that it might contain a higher concentration of the pain reliever.
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New Jersey-based Tris Pharma said the product was packaged in 0.5 oz. bottles and labeled to contain 50 mg per 1.25 mL. It was sold in lots that went to some Walmart, CVS Pharmacy and Family Dollar stores.
However, the company didn’t specify which states received the product.
In a statement, the company said there is a “remote possibility” that the higher potency of the drug can lead to permanent kidney damage in infants. Other adverse effects may include nausea, vomiting, pain below the ribs in the upper abdomen and diarrhea. Other possible adverse effects include tinnitus (ringing in the ears), headaches and stomach bleeding.
Tris Pharma said, to date, it hasn’t received any reports of adverse events related to the recall.
Ibuprofen is an over-the-counter nonsteroidal anti-inflammatory drug (NSAID) frequently used to relieve pain that is associated with headaches, dental pain, menstrual cramps, muscle aches and arthritis. It is also commonly used to reduce fevers.
The product was sold in Walmart under the “Equate” brand, in CVS under the “CVS Health” brand and in Family Dollar under the “Family Wellness” label.
The company said that the recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
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