Tris Pharma, a Monmouth Junction, New Jersey-based specialty pharmaceutical company, is expanding its voluntary recall of infant ibuprofen by adding three additional lots to its US recall. The recall applies to ibuprofen oral suspension drops, USP, 50 mg per 1.25 mL, to the retail level. Some units from these batches have been found to have higher levels of ibuprofen concentration.

The voluntary recall now includes a total of six lots. The product is used as a pain reliever/fever reducer and is packaged in one-half ounce and 1-ounce bottles.

Tris Pharma manufactures ibuprofen oral suspension drops, USP for a single customer, which markets and distributes the product to retailers.

The company says that infants already susceptible to the adverse effects of ibuprofen may be at a slightly higher risk if they receive medication from an impacted bottle and there is a remote probability that infants, who may be more susceptible to a higher potency level of drug, may be more vulnerable to permanent nonsteroidal anti-inflammatory drug (NSAID)-associated renal injury. To date (as of January 29, 2019), the company said that no serious adverse events had been reported related to the recall.

The recall follows previous issues for the company’s manufacturing facility in Monmouth Junction. In 2018, the company received a Warning Letter from the US Food and Drug Administration for GMP violations for finished pharmaceuticals, which included issues for not adequately investigating product failures and defect complaints and the related root causes and for failing to implement corrective actions and preventive actions (CAPA).

Source: Tris Pharma and FDA