US Drug Recall Register
Class II · Moderate risk Terminated Initiated Jun 7, 2022 (4 years ago)

Magnesium Hydroxide 1200 mg, Aluminum Hydroxide 1200 mg, Simethicone 120 mg per 30 mL, 30…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.

What was recalled

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

Recalling firm
Plastikon Healthcare LLC
NDC code
0904-6838-73
Origin
KS, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-1482-2022

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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