Infant Ibuprofen Recalled Due to Overdose Danger and Risk of Serious Side Effects

by Sokolove Law

Drug-maker Tris Pharma has recalled infant ibuprofen from 3 retailers, due to problems with the medication’s concentration level. The product is a liquid meant for children ages 6- to 23-months-old, sold as Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL. It comes in 0.5-ounce bottles, and was distributed to Family Dollar, Wal-Mart, and CVS Pharmacy.

This recall is due to the possibility that the amount of ibuprofen in the drug may be incorrect. Giving young children a high dosage could cause harmful side effects, such as stomach pain, vomiting, headaches, nausea, diarrhea, and ringing in the ears. In more serious cases, an overdose could lead to bleeding in the intestines or nonsteroidal anti-inflammatory drug (NSAID) kidney damage.

While doctors and parents have not reported any of these problems to date, these products must be thrown away or returned to the store, and retailers have been told to remove them from shelves.

Checking the Medicine Cabinet

If you think you may have purchased 1 of the medications affected by this recall, check the drug names and lot numbers listed below:

At Family Dollar, the drug was sold as Family Wellness Infants’ Ibuprofen Concentrated Oral Suspension. The expiration date is August 2019, the lot number is 00717024A, and the NDC number is 55319-250-23.

Wal-Mart sold the medication as Equate Infants’ Ibuprofen Concentrated Oral Suspension. The expiration dates are February 2019, April 2019, and August 2019, and the lot numbers are 00717009A, 00717015A, and 00717024A. The NDC number is 49035-125-23.

CVS Pharmacy sold the product as CVS Health Infants’ Ibuprofen Concentrated Oral Suspension. The expiration date is August 2019, the lot number is 00717024A, and the NDC number is 59779-925-23.

Anyone who has purchased and/or used this product should contact their child’s pediatrician if they notice their child having any discomfort after taking the medication. Parents can also let FDA officials know about any problems online using the FDA’s MedWatch Adverse Event Reporting program. This online form can be found here.

Red Flags at Tris Pharma

Perhaps equally as disturbing as the recall is the fact that approximately 9 months ago, Tris Pharma was given a warning by the FDA. The FDA’s letter was related to an inspection at the Tris Pharma plant in Monmouth Junction, New Jersey, which happened in February and March 2017. The recalled ibuprofen was manufactured at that facility.

In its statement to the company, the FDA warned that the facility did not have proper quality control operations, and that the facility had failed to investigate why medications did not meet the right concentrations of drug levels.

The FDA asked the plant to create clearer guidelines to assure adherence to standards, and the manufacturing of a safe product. Further, the FDA advised Tris Pharma to have an expert help them establish better quality control practices. While Tris Pharma did hire someone to fill this post in August, that did not prevent them from making a product that posed a serious threat to consumers.

While harm seems to have been avoided in this case – at least so far – the recall is yet another example of companies putting profits before people in their rush to take a product to market, and not having rigorous standards. Cutting corners may cut costs, but in this case, it could have injured some of our country’s most vulnerable and innocent citizens: our children.