infants* IBUPROFEN, Concentrated Ibuprofen Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, Dye-Free Berry Flavor, 1 FL OZ (30 mL) bottle, Distributed by Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC 49035-125-24.

Recall Number: D-0494-2019

Firm: Tris Pharma Inc.

Classification: Class II

Status: Terminated

Report Date: 20190220

Initiation Date: 20190115

Termination Date: 20230329

Reason for Recall

Superpotent Drug: recalled lots may have higher concentration of ibuprofen than amount labeled.

Product Description

infants* IBUPROFEN, Concentrated Ibuprofen Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, Dye-Free Berry Flavor, 1 FL OZ (30 mL) bottle, Distributed by Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC 49035-125-24.