Z-0856-2022Class II

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

Name: Z-0856-2022 Silatrix Oral Gel Polymerized Sucralfate Gel 10% (1 gm/10 gm
Creator: Sa3, Llc
Published: 2022-02-21
License: https://open.fda.gov/license/

SA3, LLC / initiated 2022-02-21 / Terminated

FDA source

SA3, LLC began a recall of Silatrix Oral Gel Polymerized Sucralfate Gel 10% (1 gm/10 gm on 2022-02-21. FDA classified it as Class II and gives the reason as "Due to failure of microbial testing for total aerobic microbial count (TAMC)". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0856-2022
Classification: Class II
Status: Terminated
Initiated: 2022-02-21
Posted: 2022-04-04
Terminated: 2024-05-15
Recalling firm: SA3, LLC
Product: Silatrix Oral Gel Polymerized Sucralfate Gel 10% (1 gm/10 gm
Product code: OLR Oral Wound Dressing
Reason for recall: Due to failure of microbial testing for total aerobic microbial count (TAMC).
FDA root cause: Under Investigation by firm
Action: On 02/21/2022, the firm emailed an Urgent Recall Notification to customers informing them that the recall has been initiated due to the affected lot's microbial testing results for total aerobic microbial count (TAMC exceeded specifications prior to expiry of the gel. Customer are instructed to: 1. Immediately examine your inventory and quarantine product subject to this recall. 2. Immediately discontinue use and distribution of the identified lot number. 3. To request a prepaid shipping label, complete and return the enclosed Customer Market Withdrawal Return Response Form via email at [email protected] or via fax at 888-502-1669. 4. If customer have further distributed this product to other wholesalers or pharmacies, please identify and notify them at once of this product market recall. The Recall notification and return response form should be include when notifying these customers. 5. Return the affected product to: Alexso, Inc. c/o Recall 2317 Cotner Ave Los Angeles, CA 90064 For any questions, contact the Recalling Firm at (888)-495-6078, Monday through Friday 9:00 AM to 5:00 PM PST or email at [email protected]. On 03/07/2022, the firm emailed an updated "URGENT: Medical Device Market Removal" letter which informs customers of the potential risks/harms/hazards associated with use of the affected products and added that it is recommended that physicians monitor their patents for potential adverse reactions and events as a result of use of the affected product.
Quantity in commerce: 156 units
Distribution: U.S. Nationwide distribution in the states of CA, FL and GA.
Product codes and lots: Product Number: 69420-8351-1 Lot Number: U701SF1 UDI Code: N/A

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0856-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0856-2022	Class II	Terminated	Voluntary: Firm initiated	2022-04-13	2022-04-04

Product code OLR

K202000UnclassifiedSilatrix Oral GelSa3, LLC / cleared 2020-11-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)