FDA Drug Class II — Moderate

infants* IBUPROFEN, Concentrated Ibuprofen Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, Dye-Free Berry Flavor, 0.5 FL OZ (15 mL) bottle, Distributed by Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC 49035-125-23, UPC 0 78742 02016 7.

Hazard

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

Products

infants* IBUPROFEN, Concentrated Ibuprofen Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, Dye-Free Berry Flavor, 0.5 FL OZ (15 mL) bottle, Distributed by Wal-Mart Stores, Inc., Bentonville, AR 72716
Brand
Tris Pharma Inc.
UPC
Lot #: 00717009A, Exp 02/19; 00717015A, Exp 04/19; 00717024A, Exp 08/19

Units Affected

164,304 bottles