FDA-Drug2019-02-20Class II
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.
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
35,280 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, 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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0495-2019Don't want to check this manually?
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