Drug & medication recalls High risk

MILK OF MAGNESIA USP 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 MILK OF MAGNESIA USP, 2400 mg/10 mL, Magnesium Hydroxide, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton,…
Recall number
D-1477-2022
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

MILK OF MAGNESIA USP, 2400 mg/10 mL, Magnesium Hydroxide, 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 0904-6840-72.

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