- Tris Pharma has expanded a recall of ibuprofen manufactured at the company's Monmouth Junction, New Jersey, production site.
- The drugmaker is now recalling three additional lots of infants' ibuprofen, bringing the total number to six lots. The product was sold to CVS, Walmart and Family Dollar through a single Tris customer that markets and distributes to retailers.
- In a Jan. 29 letter, Tris said some units from the six recalled lots contained ibuprofen concentrations as high as 10% above the specified limit. Tris claims there are studies wherein it was generally accepted that ibuprofen in excess of 700% of the recommended dose is when safety and toxicity concerns arise. Still, it noted that "[i]nfants already susceptible to the adverse effects of ibuprofen may be at a slightly higher risk if they receive medication from an impacted bottle."
The expanded recall is yet another setback for Tris. In addition to its infant ibuprofen woes, first detailed in a Dec. 5 announcement, the company also received a warning letter from the Food and Drug Administration last March.
Regulators took issue with how Tris was investigating product failures at its Monmouth Junction facility. They pointed to five lots of Quillivant XR, an attention deficit hyperactivity disorder drug from Pfizer, that failed dissolution testing. Tris deviated from acceptable testing methods to get the results in-line, according to the FDA, and still couldn't get one lot of drug product to pass.
Tris said in its Jan. 29 notice that the retailers should stop distributing the affected ibuprofen lots.
The company added that no serious adverse events related to the recall have been reported. However, "[t]here 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," Tris said.
Beyond Tris, the ibuprofen market has been hammered by manufacturing challenges over the last year. A technical malfunction last June caused chemicals giant BASF to shut down a bulk ibuprofen plant in Texas, leading to a shortage of the pain-killing drug.
And more recently, contract manufacturing organization Catalent reported second quarter earnings that showed its Softgel business was still being crimped by ibuprofen supply shortages.