Tris Pharma, Inc. Expands Ibuprofen Recall

January 31, 2019
Pharmaceutical Technology Editors

The company is recalling three additional lots of Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 mL because of a higher concentration of ibuprofen.

Tris Pharma, Inc. announced on January 29, 2019 that it was recalling three additional lots of Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 mL because some batches had higher levels of ibuprofen concentration up to 10% above the specified limit. This recall expands on a similar recall in December 2018.

While no adverse events associated with the recall have been reported as of January 29, infants that are already susceptible to the effects of ibuprofen may be more susceptible to the higher potency level of the recalled lots and could potentially be more vulnerable to permanent NSAID-associated renal injury, according to the company.

The recalled lots were manufactured as CVS Health: Infants’ Ibuprofen Concentrated Oral Suspension, USP, 50 mg per 1.25 mL, in 0.5 oz. bottle for CVS Pharmacy and Equate: Infants’ Ibuprofen Concentrated Oral Suspension, USP, 50 mg per 1.25 mL, in 1.0 oz. bottle for Wal-Mart Stores. The company has advised retailers to stop distributing the affected lots.

Source: FDA