MILK OF MAGNESIA USP recalled over manufacturing violations

Recall date

March 24, 2022

Source

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

Official notice title

Plastikon Healthcare LLC recalls MILK OF MAGNESIA USP, (Magnesium Hydroxide), 2400 mg/30 mL, 30 mL cup, packaged in 10 cups per tray, 10 trays per carto…

Recall number

D-0870-2022

FDA classification

Class II

Brand / firm

Plastikon Healthcare LLC

Sold / distributed

Distributed in Indiana for further distribution in the USA.

Why it was recalled

CGMP Deviations: Failure to properly investigate failed microbial testing.

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

What was recalled

MILK OF MAGNESIA USP, (Magnesium Hydroxide), 2400 mg/30 mL, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Distributed by Major Pharmaceuticals, Livonia, MI 48152, NDC 0904-6846-73.