Tris Pharma is expanding the scope of its infant Ibuprofen recall that began in November, according to the U.S. Food & Drug Administration.
The recall will now include the company's Ibuprofen oral suspension drops on the retail pharmacy level. Stores which sell the aspirin, such as Walmart and CVS, have been told to take the products off the shelf, the FDA said. The Equate and CVS Health brand Ibuprofen are now included in the recall.
Some of the units have been found to have higher levels of Ibuprofen concentration. Infants already susceptible to the adverse effects of Ibuprofen could be at a higher risk if they use the medication.
Some of the units within the recall parameters have been found to have up to a 10 percent higher dose of Ibuprofen above the specified limits, the FDA said.
Studies have shown that safety issues or toxicity are generally accepted to be a concern for infants who ingest more than 700 percent of the recommended dose.
No serious events in relation to the recall have been reported, the FDA said. The product is generally used as a pain reliever or fever reducer for infants.
Retailers have been told to stop further distribution of the affected lots. Tris Pharma offials said they have notified customers by urgent recall notice and have arranged for the return of the recalled products.
Check below for product labels that have been recalled:
