Product Safety Recalls

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SA3, LLC Recall 89687

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

SA3, LLC Recall 89687 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0856-2022
Event ID89687
Event DescriptionSilatrix Oral Gel Polymerized Sucralfate Gel 10% (1 gm/10 gm
Product TypeDevices
DistributionU.S. Nationwide distribution in the states of CA, FL and GA.
Quantity156 units
Recall ReasonDue to failure of microbial testing for total aerobic microbial count (TAMC).
Device Classification20220413
Device Code InfoProduct Number: 69420-8351-1 Lot Number: U701SF1 UDI Code: N/A
Center Classification Date20220404
Recall Initiation Date20220221
Recalling FirmSA3, LLC
Initial Notification E-Mail
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