FDA recall D-0494-2019

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.

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-0494-2019