FDA recall D-0597-2022

Product

Acetaminophen Infant Dye Free Grape Oral Suspension (160mg/5ml), 2 FL OZ (59 mL) per bottle, DISTRIBUTED BY: Wal-Mart Stores, Inc., Bentoneville, AR 72716. NDC: 49035-766-16

Reason for recall

CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2021-10-26

Report date

2022-03-02

Termination date

2023-09-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Allegan, MI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0597-2022