FDA recall Z-0856-2022
SA3, LLC · Class II · device
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
- 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
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0856-2022