The Recall Desk
HighFDA (Drugs)·D-0870-2022·Announced 2022-05-25

Milk of Magnesia Institutional Units Recalled for Manufacturing Quality Deviation

Plastikon Healthcare LLC is recalling 5,400 unit doses of Milk of Magnesia USP (Lot 20041A, exp. May 2022) due to failure to properly investigate failed microbial testing during manufacturing. The product was distributed in Indiana for further distribution nationwide.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall involving CGMP deviation with failure to properly investigate failed microbial testing. The recall presents a risk of potential product contamination due to inadequate investigation, but no illnesses or injuries have been reported. The hazard is theoretical pending proper investigation, placing this in the High severity category per the rubric.

Plain-English summary

Plastikon Healthcare LLC, distributed by Major Pharmaceuticals in Livonia, Michigan, is recalling 5,400 unit doses of Milk of Magnesia USP (2400 mg/30 mL) packaged in 30 mL cups. The affected product is Lot 20041A with an expiration date of May 2022.

The recall is due to a Current Good Manufacturing Practice (CGMP) deviation identified during manufacturing. Specifically, the manufacturer failed to properly investigate the results of failed microbial testing, which means the product may not have undergone adequate quality assurance procedures to ensure safety and efficacy.

This product is for institutional use only and was distributed in Indiana for further distribution throughout the United States.

Healthcare facilities and institutional pharmacies that received product from the affected lot should stop use immediately. Return the product to Major Pharmaceuticals or consult the distributor for proper disposition instructions.

The recalled product

Product
MILK OF MAGNESIA USP, (Magnesium Hydroxide), 2400 mg/30 mL, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Distributed by Major Pharmaceuticals, Livonia, MI 48152, NDC 0904-6846-73.
Manufacturer
Plastikon Healthcare LLC
Category
Drug — Laxative
Hazard
  • cgmp-deviation
  • 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: 20041A
  • EXP May 2022

Distribution

Distribution scope not specified by the agency.

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