The Recall Desk
CriticalFDA (Drugs)·D-1476-2022·Announced 2022-09-14

Milk of Magnesia Recalled Nationwide for Microbial Contamination

Plastikon Healthcare LLC has recalled Milk of Magnesia USP nationwide due to microbial contamination in non-sterile products. The affected lot (20071A) included approximately 24,400 institutional-use cups.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

Our severity reasoning: FDA Class I classification for microbial contamination in non-sterile pharmaceutical products meets the Critical severity threshold per the rubric.

Plain-English summary

Plastikon Healthcare LLC is recalling Milk of Magnesia USP, 2400 mg/30 mL (NDC 0904-6846-73) due to microbial contamination detected in non-sterile products. The recalled product was packaged in 10 cups per tray, with 10 trays per carton, and designated for institutional use only. The affected lot number is 20071A with an expiration date of July 2022. Approximately 24,400 cups were distributed nationwide across the United States.

Milk of Magnesia is a laxative medication. Microbial contamination of non-sterile pharmaceutical products can pose health risks to users. The FDA classified this recall as Class I, the highest severity level for drug recalls.

Institutions and consumers in possession of the affected lot should discontinue use immediately. Contact Plastikon Healthcare LLC, Major Pharmaceuticals (17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152), or your distributor for instructions on product return or proper disposal.

The recalled product

Product
MILK OF MAGNESIA USP, 2400 mg/30 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 0904-6846-73.
Manufacturer
Plastikon Healthcare LLC
Category
Drug
Hazard
  • microbial-contamination

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot# 20071A
  • EXP Jul. 2022

Distribution

Distributed nationwide across the United States.