Monmouth Junction, NJ, Tris Pharma, Inc. has voluntarily recalled three (3) lots of Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL, to the retail level.
New Jersey-based Tris Pharma, Inc. said lots sold under Walmart, CVS Pharmacy and Family Dollar brands are impacted by the recall. The products were labeled to contain 50 mg of Ibuprofen per 1.25 mL.
According to the voluntary recall Wednesday, the infant ibuprofen might contain a higher concentration of ibuprofen, leading to potential risks in infants.
The release does not specify which states received the product.
The company said there is a “remote possibility” the increased amount of ibuprofen could lead to permanent kidney injury in infants. Other adverse effects could include nausea, vomiting, stomach pain and diarrhea, along with tinnitus, headaches or possible stomach bleeding.
To date, the company says it has not received any reports of adverse events related to the recall.
The Equate ibuprofen packages sold at Walmart have a national drug code of 49035-125-23 and include lot numbers 00717009A with an expiration date of February 2019, 00717015A with an expiration date of April 2019 and 00717024A with an expiration date of August 2019.
The CVS ibuprofen packages have a national drug code of 59779-925-23 and include lot number 00717024A with an expiration date of August 2019.
The ibuprofen sold at Family Dollar and branded as Family Wellness has a national drug code of 55319-250-23 and include lot number 00717024A with an expiration date of August 2019.
Consumers who have this medication should return it or throw it away. It should not be used.
For more information on the recall, click here