FDA recall D-0495-2019

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.

Reason for recall

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

Distribution

One distributor who further distributed Nationwide in the USA.

Key facts

Status

Terminated

Initiation date

2019-01-15

Report date

2019-02-20

Termination date

2023-03-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Monmouth Junction, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0495-2019