FDA recall D-0868-2022

Plastikon Healthcare LLC · Class I · drug

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, Distribute by Major Pharmaceuticals, Livonia, MI 48152, NDC: 0904-6838-73.

Reason for recall

Microbial Contamination of Non-Sterile Products

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-0868-2022