FDA-Drug2022-09-14Class II
Magnesium Hydroxide 2400 mg, Aluminum Hydroxide 2400 mg, Simethicone 240 mg MAX, per 30 mL Oral Suspension, 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 0904-6839-73
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
88,500 cups
Manufactured in
3780 Greenway Cir, N/A, Lawrence, KS, United States
Products
Magnesium Hydroxide 2400 mg, Aluminum Hydroxide 2400 mg, Simethicone 240 mg MAX, per 30 mL Oral Suspension, 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 0904-6839-73
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1483-2022Don't want to check this manually?
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