A New Jersey company has expanded a voluntary nationwide recall of infant ibuprofen amid concerns the medication, which was destined to be sold at several major retailers, may contain a higher concentration of ibuprofen than labeled.
Tris Pharma, Inc. previously said that lots sold under Walmart, CVS Pharmacy and Family Dollar brands were impacted by the recall. On Tuesday, the company added three more lots to the recall list, affecting more products that were manufactured for CVS and Walmart.
The company says it has not received any reports of serious adverse events related to the recall.
Tris Pharma provided further information about the dosing concerns in a Tuesday release: “The reason for the recall was a potential higher concentration of Ibuprofen of less than 10% above the specified limit in some bottles from these three batches. Safety issues or toxicity is generally accepted to be a concern in infants at doses in excess of 700% of the recommended dose.”
There is a “remote possibility” that a side effect of the increased amount of ibuprofen could be permanent kidney injury in certain infants, the company’s release says. Other adverse effects could include nausea, vomiting, stomach pain and diarrhea, along with tinnitus, headaches or possible stomach bleeding.
Affected products are labeled “Infants’ Ibuprofen Concentrated Oral Suspension” and were labeled to contain 50 mg. of ibuprofen per 1.25 mL.
Lot 4718 — sold in a .5 oz. bottle with an expiration date of Dec. 2019 — and lot 00717006A — sold in a 1 oz. bottle with an expiration date of Feb. 2019 — were manufactured under the “CVS Health” label, according to the release. Lot 00717005A — sold in a 1 oz. bottle with an expiration date of Feb. 2019 — was manufactured under the “Equate” label for Walmart.
Tris Pharma says the affected products were sold to a customer that distributes the drug to retailers. Retailers of the product should stop further distribution of the affected lots, the release says.
Consumers who have a bottle of medication impacted by the recall should consult their doctor for guidance, the company’s release says.
More information about the recall is available from the company.