FDA-Drug2022-05-25Class II
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.
Plastikon Healthcare LLC
Hazard
CGMP Deviations: Failure to properly investigate failed microbial testing.
Sold states
Distributed in Indiana for further distribution in the USA.
Affected count
106,400 Unit Dose cups
Manufactured in
3780 Greenway Cir, N/A, Lawrence, KS, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0871-2022Don't want to check this manually?
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