Plastikon Healthcare LLC recalls Magnesium Hydroxide 1200mg, Aluminum Hydroxide 1200mg, Simethicone 120mg, 30 mL cup, packaged in 10 cups per tray, 10 tr
Recalled May 25, 2022 · FDA recall D-0871-2022 · Plastikon Healthcare
Hazard
CGMP Deviations: Failure to properly investigate failed microbial testing. · FDA Class II
Units
106,400 Unit Dose cups
Sold at
Distributed in Indiana for further distribution in the USA.
Description
CGMP Deviations: Failure to properly investigate failed microbial testing.
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.
Manufacturer(s)
Plastikon Healthcare LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →