Los Angeles, CA, United States
SA3, LLC recalls
1 recall recorded since 2018, most recently on 21 February 2022. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 21 February 2022
- Terminated
- 15 May 2024
- Reason
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0856-2022
- Silatrix Oral Gel Polymerized Sucralfate Gel 10% (1 gm/10 gm
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.