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FDAJune 7, 2022drug

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 recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

plastikon healthcareplastikon

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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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 — Recall Details · AllClear