Tris Pharma's recentcomes less than a year after federal regulators told the drugmaker to clean up its act, citing numerous manufacturing violations.
The New Jersey drugmaker late last monthat Walmart, CVS Pharmacy and Family Dollar stores, announcing that some batches of the medicine had overly high concentrations of ibuprofen and could cause kidney damage to infants.
In March of 2018, the U.S. Food and Drug Administration sent Tris a warning letter for inadequately investigating and addressing "product failures and significant defect complaints" at its manufacturing facility in Monmouth Junction, New Jersey. FDA inspections in May 2011, June 2012 and October 2014 found the same violations, according to the agency, which advised the company hire a regulatory compliance consultant.
Tris founder and CEO Ketan Mehta said the FDA's warning last year and the ibuprofen recall aren't connected. "We are working very closely with the FDA on both counts," he added, while declining to elaborate further.
"The warning letter to Tris did not specifically reference deficiencies concerning the ibuprofen oral suspension drops that Tris recently recalled due to superpotency," an FDA spokesperson said by email.
Tris has responded to the FDA over the last year, Peter Ciano, Tris' senior vice president, corporate development and acting chief financial officer, told CBS MoneyWatch. "I suspect it will be remedied in the near term," Ciano said of the FDA action.
Ciano directed requests for further information to Jeffrey Palmer, a vice president in charge of quality and compliance at Tris, who did not return phone calls or emailed questions.
Still, some experts said Tris' record of FDA violations is concerning.
"These strike me as red flags that there could be a longstanding and potentially systemic problem of concern to the agency," Erika Lietzan, a University of Missouri law professor and food and drug regulation expert, told CBS MoneyWatch of the agency's findings.
The FDA's letter to Tris "hints at a systemic problem that could affect more products than the specific products cited," she added in an email.
Neal Seth, a partner at law firm Wiley Rein who has counseled drugmakers on dealing with the FDA, said companies have little "wiggle room" with the agency when it comes to recalls. "The warning letter is [the FDA] saying, 'Look, we're aware as a result of inspection, here are problems that are serious and need to be addressed.'"
In its warning to Tris last year, the FDA also noted the company's role in a 2017 recall by Pfizer for Quillivant XR, an extended-release oral suspension used to treat ADHD. The agency said five lots of the drug failed dissolution testing. Pfizer marketed the drug, which was manufactured by Tris.
Pfizer no longer does business with Tris, a Pfizer spokesperson said.
Separately, Tris received at least 24 complaints about roughly 1,000 leaking or underfilled bottles of morphine sulfate oral solution between July and December 2016, the FDA noted. Tris initially found the damage likely occurred during shipment, and the defective product remained on the market for eight months before the company initiated a recall, the agency said.
"My instinct is that the company has, or had, serious [manufacturing practice] issues over a multiyear period, but whether they have turned the ship around -- or are in the middle of an orderly process of doing so -- is completely in a black box," Lietzan said. "There's no real way of knowing."
Privately held, Tris employs about 500 people and generates about $102 million in annual revenue, according to S&P Capital IQ.
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