Silatrix Oral Gel Polymerized Sucralfate Gel 10% (1 gm/10 gm
Reported: April 13, 2022 Initiated: February 21, 2022 #Z-0856-2022
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).
Details
- Recalling Firm
- SA3, LLC
- Units Affected
- 156 units
- Distribution
- U.S. Nationwide distribution in the states of CA, FL and GA.
- Location
- Los Angeles, CA
Frequently Asked Questions
What product was recalled? ▼
Silatrix Oral Gel Polymerized Sucralfate Gel 10% (1 gm/10 gm. Recalled by SA3, LLC. Units affected: 156 units.
Why was this product recalled? ▼
Due to failure of microbial testing for total aerobic microbial count (TAMC).
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 13, 2022. Severity: Moderate. Recall number: Z-0856-2022.
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