FDA recall D-0871-2022

Product

Magnesium Hydroxide 1200mg, Aluminum Hydroxide 1200mg, Simethicone 120mg, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Distributed by Major Pharmaceuticals, Livonia, MI 48152, NDC: 0904-6838-73.

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-0871-2022