# FDA recall D-0871-2022

> **Plastikon Healthcare LLC** · Class II · drug recall initiated 2022-03-24.

## 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.

## Distribution

Distributed in Indiana for further distribution in the USA.

## Key facts

- **Recall number:** D-0871-2022
- **Recalling firm:** Plastikon Healthcare LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Completed
- **Initiation date:** 2022-03-24
- **Report date:** 2022-05-25

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Lawrence, KS, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0871-2022

## Citation

> AI Analytics. FDA recall D-0871-2022. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0871-2022. Source: US FDA. Licensed CC0.

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