Tris-Pharma, the company that makes the recalled medication – Infants’ Ibuprofen Concentrated Oral Suspension – initiated the recall after finding that the drug may contain up to 10% more ibuprofen than the 50 mg per 1.25 ml stated on the labeling.
“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,” Tris-Pharma said.
The U.S. Food & Drug Administration (FDA), which monitors drugs in the U.S., said infants already susceptible to the adverse effects of ibuprofen may be at a slightly higher risk if they receive medication from an impacted bottle, in a statement issued Wednesday.
Dangerously high concentrations of ibuprofen could increase the risk of nausea, vomiting, diarrhea, stomach bleeding, and kidney damage, FDA said.
Specific products affected by the recall include:
- Walmart sells the recalled product under the “Equate” label and the National Drug Code (NDC) 49035-125-23; the products being withdrawn have the lot numbers 00717005A, 00717009A, 00717015A and 00717024A on their label.
- CVS offers it under the “CVS Health” label, with the recalled products bearing the NCD number 59779-925-23 and the lot numbers 4718, 00717006A and 00717024A.
- At Family Dollar, it’s sold under the “Family Wellness” label with the NCD 55319-250-23 and lot number 00717024A.
Source: NBC News