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.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. 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
- Affected units
- 24,400
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.
Part of a larger recall action
This product is one of 19 recalled by Plastikon Healthcare LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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