Milk of Magnesia USP — Class I drug recall D-1879-2019
Terminated recall by Plastikon Healthcare LLC, reported 2019-09-18, distributed nationwide. Microbial Contamination of Non-Sterile Products: product failed bioburden testing for Total Aerobic Microbial
| Recall number | D-1879-2019 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Plastikon Healthcare LLC, Lawrence, KS, United States |
| Recall initiated | 2019-08-30 |
| Classified | 2019-09-24 |
| Reported by FDA | 2019-09-18 |
| Terminated | 2020-11-04 |
| Distributed | Nationwide (US) |
| Quantity | 1,433 cases |
| Reason classes | microbial contamination, sterility |
| NDC | 00904-6846-73 |
| Lot numbers | 07/21, 19027D, 19027E |
Product
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.
Reason for recall
Microbial Contamination of Non-Sterile Products: product failed bioburden testing for Total Aerobic Microbial Count.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1879-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.