Drug & medication recalls Moderate risk

Tris Pharma Inc. recalls Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 mg per 1.25 mL, Dye-Free Non-Staining Berr…

Recall date
November 26, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
D-0336-2019
FDA classification
Class II
Brand / firm
Tris Pharma Inc.
Sold / distributed
One distributor in PA who further distributed Nationwide in the USA.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.

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