Infants’ ibuprofen recalled for potential high concentrations of ibuprofen

Tris Pharma issued a voluntary recall notice on Wednesday for Infants’ Ibuprofen Concentrated Oral Suspension due to products that have been found to potentially have higher concentrations of ibuprofen.

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, Inc. sold the affected lots of Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL to one customer, which distributed the lots into the US market. Tris Pharma, Inc. has notified its customer by urgent recall notice and is arranging for the return of the recalled product.

Wholesalers and retailers of the product should stop further distribution of the affected lots of Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL, which are being recalled.

They were sold at Family Dollar, Walmart and CVS.

More information about the recall is available from the company’s release.