FDA-Device2022-04-13Class II

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

SA3, LLC
Hazard

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

Sold states
U.S. Nationwide distribution in the states of CA, FL and GA.
Affected count
156 units
Manufactured in
2317 Cotner Ave, Los Angeles, CA, United States
Products
Silatrix Oral Gel Polymerized Sucralfate Gel 10% (1 gm/10 gm

Official notice

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

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