A New Jersey company that issued a voluntary recall in December of infant ibuprofen sold at Walmart, CVS Pharmacy and Family Dollar stores across the nation has expanded the recall to include three additional lots of the product.
Tris Pharma, Inc. — which last month said Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL, may potentially have higher concentrations of ibuprofen than labeled —announced the expansion Tuesday, which specifically affects CVS and Walmart stores.
The brands affected by the expansion include “CVS Health” and “Equate,” which are sold at CVS and Walmart stores, respectively. More specifically, CVS Health: Infants’ Ibuprofen Concentrated Oral Suspension sold in both 1.0 oz and 0.5 oz bottles, according to the U.S. Food and Drug Administration’s (FDA) notice, have been added to the list. Additionally, the Equate: Infants’ Ibuprofen Concentrated Oral Suspension sold in 1.0 oz bottles was as added as well.
Tris Pharma, Inc. said the concentration could be as high as 10 percent above the specified limit. Infants already susceptible to the adverse effects of ibuprofen could be at a slightly higher risk if given medication from a recalled bottle. In its statement, the company said there is a “remote possibility” an elevated level of ibuprofen could lead to permanent kidney damage in babies.
Other potential adverse health effects include nausea, vomiting, stomach pain and diarrhea.
The company said Tuesday it had not received any reports of adverse effects pertaining to the recall.