FDA-Drug2019-02-20Class II
infants* IBUPROFEN, Concentrated Ibuprofen Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, Dye-Free Berry Flavor, 1 FL OZ (30 mL) bottle, Distributed by Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC 49035-125-24.
Tris Pharma Inc.
Hazard
Superpotent Drug: recalled lots may have higher concentration of ibuprofen than amount labeled.
Sold states
One distributor who further distributed Nationwide in the USA.
Affected count
35,328 bottles
Manufactured in
2033 US Highway 130, N/A, Monmouth Junction, NJ, United States
Products
infants* IBUPROFEN, Concentrated Ibuprofen Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, Dye-Free Berry Flavor, 1 FL OZ (30 mL) bottle, Distributed by Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC 49035-125-24.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0494-2019Don't want to check this manually?
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