MONMOUTH JUNCTION, N.J., –  Tris Pharma has issued a recall for infant ibuprofen sold by CVS, Family Dollar and Walmart. 

The three recalled lots of Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL may have concentrations of ibuprofen that are too high and therefore could be dangerous, according to the recall announcement.

The over-the-counter liquid pain reliever and fever reducer is meant for infants who are between the ages of 6 months and 23 months old. Adverse events from the medication may include nausea, vomiting, upper abdominal pain, diarrhea, gastrointestinal pain, ringing in the ears and headache, although no adverse events related to the recalled ibuprofen have been reported, according to Tris Pharma.

“There is a remote possibility that infants, who may be more susceptible to a higher potency level of drug, and therefore may be more vulnerable to permanent NSAID-associated renal injury,” the recall announcement said.

The product is used as a pain reliever/fever reducer and was packaged in 0.5 oz. bottles for the recalled lots listed below:

NDC	LOT	EXPIRATION	DESCRIPTION	COMPANY
49035-125-23	00717009A 00717015A 00717024A	02/19 04/19 08/19	Equate: Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, 0.5 oz. bottle	Wal-Mart Stores Inc
59779-925-23	00717024A	08/19	CVS Health: Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, 0.5 oz. bottle	CVS Pharmacy
55319-250-23	00717024A	08/19	Family Wellness: Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, 0.5 oz. bottle	Family Dollar Services Inc.

 

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.

Consumers with questions regarding this recall can contact Tris Customer Service at 732-940-0358 (Monday through Friday, 8:00am ET- 5:00pm PT) or via email at Customer Service Email .  Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of the product lots subject to this recall may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.