FDA-Drug2022-09-14Class II
Magnesium Hydroxide 1200 mg, Aluminum Hydroxide 1200 mg, Simethicone 120 mg per 30 mL, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152, NDC 0904-6838-73
Plastikon Healthcare LLC
Hazard
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Sold states
Distributed Nationwide in the USA
Affected count
521,700 cups
Manufactured in
3780 Greenway Cir, N/A, Lawrence, KS, United States
Products
Magnesium Hydroxide 1200 mg, Aluminum Hydroxide 1200 mg, Simethicone 120 mg per 30 mL, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152, NDC 0904-6838-73
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1482-2022Don't want to check this manually?
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