Tris Pharma Inc. recalls Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 mg per 1.25 mL, Dye Free, Non-staining Ber…
- Recall date
- January 15, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0493-2019
- FDA classification
- Class II
- Brand / firm
- Tris Pharma Inc.
- Sold / distributed
- One distributor who further distributed Nationwide in the USA.
Why it was recalled
Superpotent Drug: recalled lots may have higher concentration of ibuprofen than amount labeled.
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: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 39338 3, NDC 59779-925-23.
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