Z-0856-2022 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- April 13, 2022
- Initiation Date
- February 21, 2022
- Termination Date
- May 15, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 156 units
Product Description
Silatrix Oral Gel Polymerized Sucralfate Gel 10% (1 gm/10 gm
Reason for Recall
Due to failure of microbial testing for total aerobic microbial count (TAMC).
Distribution Pattern
U.S. Nationwide distribution in the states of CA, FL and GA.
Code Information
Product Number: 69420-8351-1 Lot Number: U701SF1 UDI Code: N/A