Tris Pharma has expanded its voluntary recall of infant ibuprofen because it may contain overly high concentrations of the drug.
This recall expands the scope of its November 2018 recall by adding three (3) additional lots of Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 mL, to the retail (pharmacy) level. Some units from these batches have been found to have higher levels of Ibuprofen concentration.
The affected brands include CVS health and Equate and are sold at Walmart, CVS and Family Dollar stores.
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 renal injury.
Tris Pharma said to date, no serious adverse events have been reported related to this recall.
For more on this recall, click here
