Recall archive / FDA device enforcement
Silatrix Oral Gel Polymerized Sucralfate Gel 10% (1 gm/10 gm — FDA record Z-0856-2022
Reported terminated
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Feb 21, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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).
- Classification
- Class II
- Recalling firm
- SA3, LLC
- Quantity
- 156 units
- Agency-reported status
- Terminated
- Source record identifier
- Z-0856-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Product Number: 69420-8351-1 Lot Number: U701SF1 UDI Code: N/A |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
U.S. Nationwide distribution in the states of CA, FL and GA.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Apr 13, 2022
- Recall initiation date
- Feb 21, 2022
- Center classification date
- Apr 4, 2022
- Termination date
- May 15, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.