Magnesium Hydroxide 2400 mg recalled over manufacturing violations

Recall date

June 7, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Plastikon Healthcare LLC recalls Magnesium Hydroxide 2400 mg, Aluminum Hydroxide 2400 mg, Simethicone 240 mg MAX, per 30 mL Oral Suspension, 30 mL cup,…

Recall number

D-1483-2022

FDA classification

Class II

Brand / firm

Plastikon Healthcare LLC

Sold / distributed

Distributed Nationwide in the USA

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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