FDAJanuary 15, 2019drug

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 recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

tris pharmatris

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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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. — Recall Details · AllClear