New Jersey-based drugmaker Tris Pharma has voluntarily recalled three lots of its ibuprofen product for babies following the company’s discovery that some packages contained higher amounts of ibuprofen than may be safe. The medicine is sold at Walmart Inc. (NYSE: WMT), CVS Health Corp. (NYSE: CVS) and Family Dollar stores, according to the company’s announcement.
At Walmart, the product is sold under the “Equate” brand. CVS sells the medicine under its “CVS Health” brand, and Family Dollar sells it under the “Family Wellness” brand. The recalled product is further identified as “ibuprofen concentrated oral suspension, USP (NSAID) 50 mg per 1.25 mL, 0.5 oz. bottle.” NSAID refers generally to non-steroidal anti-inflammatory drugs.
Tris said there is a “remote possibility” that some infants who may be susceptible to higher doses of ibuprofen “may be more vulnerable to permanent NSAID-associated renal injury.” The company noted that to date it has received no reports of adverse effects related to the recalled products.
Tris said it sold the affected lots to one customer that then distributed the product into the U.S. market. The drugmaker has notified the distributor by “urgent recall notice” and is also arranging for the return of the recalled product.
At Walmart, the affected lot numbers are 00717009A with an expiration date of 02/19, 00717015A expiring 04/19 and 00717024A expiring 08/19. The affected lot number at CVS and Family Dollar stores is 00717024A expiring 08/19.
Adverse effects that may be experienced by infants who have been given the medicine are nausea, vomiting, epigastric pain, or more rarely, diarrhea. Tinnitus, headache and gastrointestinal bleeding are also possible adverse effects.