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.