CLASS I Drug recall · Reported 18 Sep 2019 · FDA Enforcement Report
Milk of Magnesia USP, 2400 mg recalled by Plastikon Healthcare
Plastikon Healthcare is recalling Milk of Magnesia USP, 2400 mg/, Magnesium Hydroxide 2400 mg unit dose cups, For, distributed nationwide in the US. The recall was initiated on 30 Aug 2019 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1879-2019
- FDA event ID
- 83693
- Recalling firm
- Plastikon Healthcare, Lawrence, KS
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 30 Aug 2019
- FDA classified
- 24 Sep 2019
- Reported
- 18 Sep 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
Timeline
| 30 Aug 2019 | Recall initiated by company | |
| 18 Sep 2019 | Published in enforcement report | +19 days |
| 24 Sep 2019 | Classified by FDA | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Microbial Contamination of Non-Sterile Products: product failed bioburden testing for Total Aerobic Microbial Count.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Milk of Magnesia USP, 2400 mg/30 mL, Magnesium Hydroxide 2400 mg, 30 mL unit dose cups, For Institutional Use Only, packaged in 100-count cartons of 10 trays x 10 unit dose cups, Major Pharmaceuticals, Livonia, MI 48152, NDC 0904-6846-73.
Where it was distributed
One distributor who further distributed Nationwide in the USA.
Questions about this recall
Why was it recalled?
Microbial Contamination of Non-Sterile Products: product failed bioburden testing for Total Aerobic Microbial Count.
Which lots are affected?
Lots: 19027D, 19027E, Exp 07/21
Where was it sold?
One distributor who further distributed Nationwide in the USA.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Plastikon Healthcare
All 25| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Guaifenesin And Dextromethorphan 200-20 mg/ cup recalled | Plastikon Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS I | Magnesium Hydroxide 2400 mg, Aluminum Hydroxide 2400 mg recalled | Plastikon Healthcare | Sterility | Nationwide |
| Drug | CLASS II | Guaifenesin And Dextromethorphan 100 mg-10 mg/ cup recalled | Plastikon Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Correctdose Children's Cough & Chest Congestion DM recalled | Plastikon Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Milk OF Magnesia USP, 2400 mg/, Magnesium Hydroxide cup recalled | Plastikon Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
Other Milk Of Magnesia recalls
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Milk OF Magnesia USP, 2400 mg/, Magnesium Hydroxide cup recalled | Plastikon Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS I | Milk OF Magnesia USP, 2400 mg/, Magnesium Hydroxide cup recalled | Plastikon Healthcare | Sterility | Nationwide |
| Drug | CLASS I | Milk OF Magnesia USP, 2400 mg/, Magnesium Hydroxide cup recalled | Plastikon Healthcare | Sterility | Nationwide |
| Drug | CLASS II | Milk OF Magnesia USP, 2400 mg/, Magnesium Hydroxide cup recalled | Plastikon Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Milk OF Magnesia USP, (Magnesium Hydroxide), 2400 mg/ cup recalled | Plastikon Healthcare | Manufacturing (CGMP) Deviations | IN |