FDA recall D-0335-2019

Product

infants* IBUPROFEN, Concentrated Ibuprofen Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, Dye-Free Berry Flavor, 0.5 FL OZ (15 mL) bottle, Distributed by Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC 49035-125-23, UPC 0 78742 02016 7.

Reason for recall

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

Distribution

One distributor in PA who further distributed Nationwide in the USA.

Key facts

Status

Terminated

Initiation date

2018-11-26

Report date

2018-12-26

Termination date

2021-04-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

Monmouth Junction, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0335-2019