FDA recall D-0869-2022

Product

Acetaminophen Oral Solution, USP 650mg/ 20.3 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Distributed by Major Pharmaceuticals, Livonia, MI 48152, NDC: 0904-6820-76.

Reason for recall

CGMP Deviations: Failure to properly investigate failed microbial testing.

Distribution

Distributed in Indiana for further distribution in the USA.

Key facts

Status

Completed

Initiation date

2022-03-24

Report date

2022-05-25

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lawrence, KS, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0869-2022