FDA Medical Device Recalls (openFDA)
SA3, LLC: Silatrix Oral Gel Polymerized Sucralfate Gel 10% (1 gm/10 gm
- Recall number
- Z-0856-2022
- Recalling firm
- SA3, LLC
- Product
- Silatrix Oral Gel Polymerized Sucralfate Gel 10% (1 gm/10 gm
- Status
- Terminated
- Initiated
- 2022-02-21
- Posted
- not on file
- Terminated
- 2024-05-15
- Reason
- Due to failure of microbial testing for total aerobic microbial count (TAMC).
- 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 info@alexso.com 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 info@alexso.com. 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
- 156 units
- Distribution
- U.S. Nationwide distribution in the states of CA, FL and GA.
- Lot, serial or model codes
- Product Number: 69420-8351-1 Lot Number: U701SF1 UDI Code: N/A
- 510(k) numbers
- ["K202000"]
- PMA numbers
- not on file
- Product code
- OLR
- Firm FEI
- 3015256319
- Firm city
- Los Angeles
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28