SA3, LLC recalls Silatrix Oral Gel Polymerized Sucralfate Gel 10% (1 gm/10 gm

Recall date

February 21, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0856-2022

FDA classification

Class II

Brand / firm

SA3, LLC

Sold / distributed

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

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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