FDA Drug recall D-0871-2022
Magnesium Hydroxide 1200mg, Aluminum Hydroxide 1200mg, Simethicone 120mg, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For…
- FDA Drug
- Class II
- completed
- Published 2022-05-25
On 2022-05-25 the FDA classified a Class II recall of Magnesium Hydroxide 1200mg, Aluminum Hydroxide 1200mg, Simethicone 120mg, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For… by Plastikon Healthcare, citing CGMP Deviations: Failure to properly investigate failed microbial testing.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0871-2022 |
| Classification | Class II |
| Status | completed |
| Initiated | 2022-03-24 |
| Published | 2022-05-25 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Plastikon Healthcare |
| Distribution | IN |
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
CGMP Deviations: Failure to properly investigate failed microbial testing.
Identifiers
| code_info | Lot: 20042A, 20043A, 20045A, 20046A, 20047A, EXP May 2022 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0871-2022%22
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