New Jersey pharmaceutical company Tris Pharma, Inc. has expanded its recall of infant ibuprofen after finding additional batches that might contain a higher dosage than is stated on the product.
The three additional lots of the drug, sold as a store brand at CVS and Walmart, could contain dangerously high concentrations of the pain/fever reducer. The expansion of the recall follows the initial warning, which came early last December. (Three store brands sold at Family Dollar were also part of that initial warning.)
“Some units from these six lots have been found to contain Ibuprofen as high as 10% above the specified limit,” the Food and Drug Administration said in a statement announcing the additional recall. “To date, no serious adverse events have been reported related to this recall.”
Two of the newly recalled lots are from CVS (under the CVS Health label)—4718 (expires 12/19) and 00717006A (expires 2/19). At Walmart the newly recalled lot, found under the Equate label, is 00717005A (expires 2/19).
The previously recalled lots from Walmart are 00717009A (expires 02/19), 00717015A (expires 04/19), and 00717024A (expires 08/19). At CVS, the previously recalled lot is 00717024A (expires 08/19). And at Family Dollar, the recalled lot is 00717024A (expires 08/19).
Consumers are urged to discard the medicine or return it to the store.
Dosage problems are nothing new in children’s medicine. Last August, Pfizer recalled some Children’s Advil for fear of overdose.