# FDA recall D-1342-2022

> **MEDEK LLC** · Class I · drug recall initiated 2020-09-09.

## Product

M Hand Sanitizer Ethyl Alcohol Antiseptic 80%v/v, Topical Solution 128 oz/3,785 mL, Made in Mexico by: Grupo Plast-Y-Kosas S.A. de C.V. Puebla 105 Col. Rodriguez Reynosa, Tam, Mexico C.P. 88630, NDC Code:  77797-001-01, Distributed by: Medek, LLC 315 E. Business Hwy 83 Alamo, TX 78516, NDC Code: 75432-001-02.

## Reason for recall

Chemical Contamination and Subpotent Drug: FDA analysis found product to contain methanol and below label claim for ethanol.

## Distribution

Texas

## Key facts

- **Recall number:** D-1342-2022
- **Recalling firm:** MEDEK LLC
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2020-09-09
- **Report date:** 2022-08-24
- **Termination date:** 2024-08-23

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Alamo, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1342-2022

## Citation

> AI Analytics. FDA recall D-1342-2022. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/D-1342-2022. Source: US FDA. Licensed CC0.

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