Tris Pharma Inc. said it was voluntarily recalling some lots of infant ibuprofen for being too strong, and putting users at risk of being vulnerable to permanent renal injury.
The Monmouth Junction, N.J.-based drugmaker said the three lots of “Infants’ Ibuprofen Concentrated Oral Suspension” pain reliever and fever reducer, packaged in 0.5 ounce bottles, were sold in Walmart, CVS Pharmacy and Family Dollar stores.
The recalled lots sold in Walmart stores had expiration dates of February 2019, April 2019 and August 2019, while those sold in CVS and Family Dollar stores had expiration dates of just August 2019.
The lots have been found by the company to potentially have higher concentrations of ibuprofen.
“There is a remote possibility that infants, who may be more susceptible to a higher potency level of drug, and therefore may be more vulnerable to permanent NSAID-associated renal injury,” the company said in a statement Wednesday. “Adverse effects that may be experienced are nausea, vomiting, epigastric pain, or more rarely, diarrhea.”
Tinnitus, or ringing in the ears, headaches and gastrointestinal bleeding are also possible “adverse effects,” the company said.
Tris said it has not received any reports of adverse events related to the products subject to the recall.
The company said it had sold the recalled lots to one customer, which distributed them into the U.S. market.
A Tris spokesperson was not immediately available for comment.
About nine months ago, the company had received a “warning letter” from the U.S. Food and Drug Administration regarding an inspection of its drug manufacturing facility in Monmouth Junction conducted from February 2017 to March 2017.
Among the concerns listed by the FDA were failures to “thoroughly investigate any unexplained or failure of a batch or any of its components to meet any of its specifications” and to establish adequate written procedures for production and process control. The FDA said the company was responsible for investigating and resolving all deficiencies, and recommended engaging a consultant to assist in meeting current good manufacturing practice requirements.
Tris followed by announcing in August the hiring Jeffery Palmer as its new head of quality and compliance.