Drug maker Tris Pharma is expanding a recall of infant ibuprofen oral suspension drops, because the product may contain higher-than-specified levels of ibuprofen that could harm infants' kidneys.
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The original recall last November was for three lots of ibuprofen oral suspension drops, USP, 50 mg per 1.25 mL. The expanded recall adds three more lots.
The products--used as a pain reliever/fever reducer and packaged in oz. and 1 oz. bottles--were sold under different names at various pharmacies: Equate at Wal-Mart, CVS Health at CVS, and Family Wellness at Family Dollar, the company said in a statement.
"Infants already susceptible to the adverse effects of ibuprofen may be at a slightly higher risk if they receive medication from an impacted bottle. There is a remote probability that infants, who may be more susceptible to a higher potency level of drug, may be more vulnerable to permanent NSAID-associated (kidney) injury," according to the news release.
"Some units from these six lots have been found to contain ibuprofen as high as 10 percent above the specified limit. Studies have shown that safety issues or toxicity is generally accepted to be a concern in infants at doses in excess of 700 percent of the recommended dose. To date, no serious adverse events have been reported related to this recall," the company said.
For more information about the recall, consumers can call Tris Pharma at 732-940-0358.Contact a healthcare provider if you've experienced any problems that may be related to taking or using this drug product, the company advised.
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