infants* IBUPROFEN, Concentrated Ibuprofen Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, Dye-F...
FDA Recall #D-0335-2019 — Class II — November 26, 2018
Product Description
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.
Reason for Recall
Superpotent Drug: recalled lots may have higher concentration of ibuprofen.
Recalling Firm
Tris Pharma Inc. — Monmouth Junction, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
164,304 bottles
Distribution
One distributor in PA who further distributed Nationwide in the USA.
Code Information
Lot #: 00717009A, Exp 02/19; 00717015A, Exp 04/19; 00717024A, Exp 08/19
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated