Tris Pharma Inc. recalls infants* IBUPROFEN, Concentrated Ibuprofen Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, Dye-Free Berry Flavor, 1 FL
Recalled February 20, 2019 · FDA recall D-0494-2019 · Tris Pharma
Hazard
Superpotent Drug: recalled lots may have higher concentration of ibuprofen than amount labeled. · FDA Class II
Units
35,328 bottles
Sold at
One distributor who further distributed Nationwide in the USA.
Description
Superpotent Drug: recalled lots may have higher concentration of ibuprofen than amount labeled.
Product
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.
Manufacturer(s)
Tris Pharma Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →