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Recall Observatory FDA recall evidence

Device product

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

Z-0856-2022

February 21, 2022

Class II

Product summary

Firm
SA3, LLC
Event
Event 89687
Status
Terminated
Classification
Class II
Quantity
156 units
Official record key
device-enforcement:Z-0856-2022

Official wording

Reason: Due to failure of microbial testing for total aerobic microbial count (TAMC).

Code information: Product Number: 69420-8351-1 Lot Number: U701SF1 UDI Code: N/A

Distribution pattern: U.S. Nationwide distribution in the states of CA, FL and GA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Due to failure of microbial testing for total aerobic microbial count (TAMC).