FDA Device recall Z-0856-2022
Silatrix Oral Gel Polymerized Sucralfate Gel 10% (1 gm/10 gm
- FDA Device
- Class II
- terminated
- Published 2022-04-13
On 2022-04-13 the FDA classified a Class II recall of Silatrix Oral Gel Polymerized Sucralfate Gel 10% (1 gm/10 gm by Sa3, citing due to failure of microbial testing for total aerobic microbial count (TAMC).
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0856-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-02-21 |
| Published | 2022-04-13 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Sa3 |
| Distribution | US |
Product
Silatrix Oral Gel Polymerized Sucralfate Gel 10% (1 gm/10 gm
Reason
Due to failure of microbial testing for total aerobic microbial count (TAMC).
Identifiers
| code_info | Product Number: 69420-8351-1 Lot Number: U701SF1 UDI Code: N/A |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0856-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.