Magnesium Hydroxide 1200mg recalled over sterility concerns

Recall date

March 24, 2022

Source

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

Official notice title

Plastikon Healthcare LLC recalls Magnesium Hydroxide 1200mg, Aluminum Hydroxide 1200mg, Simethicone 120mg, 30 mL cup, packaged in 10 cups per tray, 10 t…

Recall number

D-0868-2022

FDA classification

Class I

Brand / firm

Plastikon Healthcare LLC

Sold / distributed

Distributed in Indiana for further distribution in the USA.

Why it was recalled

Microbial Contamination of Non-Sterile Products

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Magnesium Hydroxide 1200mg, Aluminum Hydroxide 1200mg, Simethicone 120mg, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Distribute by Major Pharmaceuticals, Livonia, MI 48152, NDC: 0904-6838-73.