SA3, LLC 2022-04-13 Health serious FDA
Health · FDA · Recall #FDA-Z-0856-2022
Silatrix Oral Gel Polymerized Sucralfate Gel 10% (1 gm/10 gm Recall
Issued April 13, 2022 · SA3, LLC
In April 2022, SA3, LLC recalled the Silatrix Oral Gel Polymerized Sucralfate Gel 10% (1 gm/10 gm, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Due to failure of microbial testing for total aerobic microbial count (TAMC).
What you should do
- 1 Stop using Silatrix Oral Gel Polymerized Sucralfate Gel 10% (1 gm/10 gm right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact SA3, LLC to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- SA3, LLC
- Category
- Health
- Recall date
- April 13, 2022
- Units affected
- Not reported
- Sold at
- U.S. Nationwide distribution in the states of CA, FL and GA.
- Recall number
- FDA-Z-0856-2022
- Made in
- United States
- Issuing agency
- FDA
In context
- SA3, LLC has 1 recall in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 870th Health recall we've logged in 2022.