# FDA recall D-1482-2022

> **Plastikon Healthcare LLC** · Class II · drug recall initiated 2022-06-07.

## Product

Magnesium Hydroxide 1200 mg, Aluminum Hydroxide 1200 mg, Simethicone 120 mg per 30 mL, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152, NDC 0904-6838-73

## Reason for recall

CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.

## Distribution

Distributed Nationwide in the USA

## Key facts

- **Recall number:** D-1482-2022
- **Recalling firm:** Plastikon Healthcare LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2022-06-07
- **Report date:** 2022-09-14
- **Termination date:** 2025-06-25

- **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-1482-2022

## Citation

> AI Analytics. FDA recall D-1482-2022. Retrieved 2026-06-05 from https://api.ai-analytics.org/recall/D-1482-2022. Source: US FDA. Licensed CC0.

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