Tris Pharma, which first recalled potentially harmful infants' ibuprofen in December, is adding lots to the recall.
The New Jersey-based company, which in December began a recall to the consumer level of three lots of Infants’ Ibuprofen Concentrated Oral Suspension, USP 50 mg per 1.25 mL, has now added three more lots to the effort. The products were sold in Walmart, CVS and Family Dollar stores
The product was produced by its Tris Pharma unit, whose plant in Monmouth Junction, New Jersey, was slapped last year with an FDA warning letter for its lack of urgency about investigating product failures.
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The drugmaker has said there is a remote possibility that infants “susceptible to a higher potency level of drug” could end up with permanent kidney damage from the nonsteroidal anti-inflammatory drug. Tris has not received any reports of adverse events, but reactions can include nausea, vomiting and stomach pain.
Nearly a year ago, the FDA criticized the Tris manufacturing facility in New Jersey for the company's inadequate investigation of defect complaints and product failures. The agency said Tris “lacked thorough investigations into root causes, and failed to implement prompt and effective corrective actions and preventative actions.”