Magnesium Hydroxide 2400 mg recalled over sterility concerns

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-1479-2022

FDA classification

Class I

Brand / firm

Plastikon Healthcare LLC

Sold / distributed

Distributed Nationwide 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 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