# FDA recall Z-0856-2022

> **SA3, LLC** · Class II · device recall initiated 2022-02-21.

## Product

Silatrix Oral Gel Polymerized Sucralfate Gel 10% (1 gm/10 gm

## Reason for recall

Due to failure of microbial testing for total aerobic microbial count (TAMC).

## Distribution

U.S. Nationwide distribution in the states of CA, FL and GA.

## Key facts

- **Recall number:** Z-0856-2022
- **Recalling firm:** SA3, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2022-02-21
- **Report date:** 2022-04-13
- **Termination date:** 2024-05-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Los Angeles, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0856-2022

## Citation

> AI Analytics. FDA recall Z-0856-2022. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0856-2022. Source: US FDA. Licensed CC0.

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