# FDA recall D-0646-2021

> **DIBAR NUTRICIONAL S DE RL DE CV** · Class II · drug recall initiated 2021-05-11.

## Product

ProtectoRx (ethyl alcohol 70%), packaged in a) 2 FL OZ (59 mL), NDC 75408-002-01 and b) 16 FL OZ (473.2 mL), NDC 75408-002-02 bottles, Imported by: Dibar Labs, LLC., Sugar Land, TX  77479; Distributed by: PR Trading LLC, PO Box 19647, San Juan, PR  00910, Made in Mexico.

## Reason for recall

CGMP Deviations: Other lots and products of hand sanitizer recalled because they were manufactured under the same conditions as the product lots found to contain methanol.

## Distribution

Distributed Nationwide in the USA

## Key facts

- **Recall number:** D-0646-2021
- **Recalling firm:** DIBAR NUTRICIONAL S DE RL DE CV
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2021-05-11
- **Report date:** 2021-07-07
- **Termination date:** 2023-03-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Morelia, N/A, Mexico

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0646-2021

## Citation

> AI Analytics. FDA recall D-0646-2021. Retrieved 2026-07-16 from https://api.ai-analytics.org/recall/D-0646-2021. Source: US FDA. Licensed CC0.

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