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FDAFDA · Food and drugs·Recall number D-1483-2022

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

Published September 14, 2022 · Recall initiated: June 7, 2022

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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

What to do

Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recall details

Manufacturer
Plastikon Healthcare LLC
Distributor
Distributed Nationwide in the USA
Lot
Lot # 20084A, 20086A, EXP Aug. 2022; 21074A, 21077A, EXP Jul. 2023
Risk classification
Class II
Area (FDA)
drug
Country
United States

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