Drug recall
Milk of Magnesia USP, 2400 mg/30 mL, Magnesium Hydroxide 2400 mg, 30 mL unit dose cups, For Institutional Use…
FDA recall event 83693 · Class I · Plastikon Healthcare LLC
Key facts
| Event ID | 83693 |
|---|---|
| Recall numbers | D-1879-2019 |
| Recalling firm | Plastikon Healthcare LLC |
| Product type | Drugs |
| Products | 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… |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Microbial Contamination of Non-Sterile Products: product failed bioburden testing for Total Aerobic Microbial Count. |
| Initiation date | Aug 30, 2019 |
| Report date | Sep 18, 2019 |
| Termination date | Nov 4, 2020 |
| City | Lawrence |
| State | KS |
| Country | United States |
| FEI number | 3009840089 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: