Tris Pharma Inc. recalls Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 mg per 1.25 mL, Dye Free, Non-staining Berr
Recalled February 20, 2019 · FDA recall D-0495-2019 · Tris Pharma
Hazard
Superpotent Drug: recalled lots may have higher concentration of ibuprofen than amount labeled. · FDA Class II
Units
35,280 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, Non-staining Berry Flavor, 1 FL OZ (30 mL) bottle, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 39961 3, NDC 50428-1252-4.
Manufacturer(s)
Tris Pharma Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →