Tris Pharma Inc. recalls infants* IBUPROFEN, Concentrated Ibuprofen Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, Dye-Free Berry Flavor, 0.5…
- Recall date
- November 26, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0335-2019
- 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 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.
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