Magnesium Hydroxide 1200mg — Class II drug recall D-0871-2022
Completed recall by Plastikon Healthcare LLC, reported 2022-05-25, distributed in IN. CGMP Deviations: Failure to properly investigate failed microbial testing.
| Recall number | D-0871-2022 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Plastikon Healthcare LLC, Lawrence, KS, United States |
| Recall initiated | 2022-03-24 |
| Classified | 2022-05-13 |
| Reported by FDA | 2022-05-25 |
| Distributed | IN |
| Quantity | 106,400 units |
| Reason classes | microbial contamination, cgmp |
| NDC | 00904-6838-73 |
| Lot numbers | 20042A, 20043A, 20045A, 20046A, 20047A |
| Expiration dates | 2022-05-20 |
Product
Magnesium Hydroxide 1200mg, Aluminum Hydroxide 1200mg, Simethicone 120mg, 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: 0904-6838-73.
Reason for recall
CGMP Deviations: Failure to properly investigate failed microbial testing.
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-0871-2022. 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.