Following a nationwide recall on a common medication for infants issued in December, the Food and Drug Administration (FDA) announced this week that it, along with the pharmaceutical company, are expanding its scope and pulling more off store shelves. On Jan. 29, the FDA expanded its recall of baby ibuprofen sold at popular stores across the country and here's everything parents need to know.
New Jersey-based pharmaceutical company Tris Pharma issued an expanded voluntary recall of its infant liquid ibuprofen sold at Walmart and CVS over safety concerns, according to the FDA's recall notice. The company initially recalled this product in both outlets as well as Family Dollar, which does not appear to be involved in this latest expanded recall, back in December 2018. Now, Tris Pharma has added three new lots to the recall of Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 ml.
The issue behind the recall is the concentration of ibuprofen in this medication; it seems there is a risk that the dosage is too high and could make infants who ingest the oral suspension drops sick. "Infants already susceptible to the adverse effects of ibuprofen may be at a slightly higher risk if they receive medication from an impacted bottle," the FDA's recall notice reads. "There is a remote probability that infants, who may be more susceptible to a higher potency level of drug, may be more vulnerable to permanent NSAID-associated renal injury."
The FDA noted that some units in the expanded recall have been found to contain ibuprofen as high as 10 percent "above the specified limit." If a child is given drops with a higher concentration of ibuprofen, they could experience nausea, vomiting, diarrhea, headache, stomach bleeding, and kidney damage, according to NBC News. Fortunately, though, the FDA and Tris Pharma are not aware of any "serious adverse events" happening related to this recall.
Romper's requests for comment from Walmart and CVS regarding the expanded recall were not immediately returned. Tris Pharma, however, stated in a news release that it has "notified its customer by urgent recall notice and has arranged for the return of recalled products from retailers and distributors." The company also stated that "retailers should stop further distribution of the affected lots."
Family Dollar previously told Romper in a statement in December that they were aware of the product recall and that they were are complying.
CVS: Sold under the "CVS Health" label and includes lot numbers 4718 (expiration date: December 2019), 00717006A (expiration date: February 2019), and 00717024A (expiration date: August 2019).
Walmart: Sold under the "Equate" store brand name, and the affected lot numbers include 00717005A (expiration date: February 2019), 00717009A (expiration date: February 2019), 00717015A (expiration date: April 2019), and 00717024A (expiration date: August 2019).
Family Dollar: Previously announced, sold under the "Family Wellness" label with the lot number 00717024A (expiration date: August 2019).
For more information about the recall or if your child has suffered an adverse effects from consuming a recalled product, customers can call Tris Pharma at 732-940-0358, Monday through Friday, 8 a.m. (EST) to 5 p.m. (PST). And, of course, if you have any immediate concerns, be sure to see your health care provider.