Tris Pharma has voluntarily recalled three lots of Infants' Ibuprofen Concentrated Oral Suspension because the products have been found to potentially have higher concentrations of ibuprofen.
NJ-based Tris sold the affected lots to one customer, which distributed the lots into the U.S. market, specifically Walmart, CVS and Family Dollar.
The drugmaker says there is a remote possibility that infants, who may be more susceptible to a higher potency level of drug, may be more vulnerable to permanent NSAID-associated renal injury. Adverse effects that may be experienced are nausea, vomiting, epigastric pain, or more rarely, diarrhea.
Recently, Tris, who specializes in manufacturing medications with unusual delivery systems, acquired NextWave Pharmaceuticals, a Pfizer subsidiary, including two key ADHD treatments. Tris has been working to rectify inherited production issues that have limited supplies of these drugs.
Read the press release