Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 mg per 1.25 mL, Dye-...
FDA Recall #D-0336-2019 — Class II — November 26, 2018
Product Description
Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 mg per 1.25 mL, Dye-Free Non-Staining Berry Flavor, 0.5 FL OZ (15 mL) bottle, Distributed by Family Dollar Services, Inc., 10301 Monroe Road, Matthews, NC 28105, NDC 55319-250-23, UPC 0 32251 03374 2.
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
19,488 bottles
Distribution
One distributor in PA who further distributed Nationwide in the USA.
Code Information
Lot #: 00717024A, Exp 08/19
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated