# FDA recall D-1484-2022

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

## Product

Acetaminophen Oral Solution 160 mg / 5 mL, 5 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 0904-6738-70

## 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-1484-2022
- **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-1484-2022

## Citation

> AI Analytics. FDA recall D-1484-2022. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/D-1484-2022. Source: US FDA. Licensed CC0.

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