FDA-Drug2018-12-26Class II

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.

Tris Pharma Inc.
Hazard

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

Sold states
One distributor in PA who further distributed Nationwide in the USA.
Affected count
164,304 bottles
Manufactured in
2033 US Highway 130, Monmouth Junction, NJ, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0335-2019

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