FDAClass IIApril 13, 2022

Silatrix Oral Gel Polymerized Sucralfate Gel 10% recall: Contamination

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

Why was Silatrix Oral Gel Polymerized Sucralfate Gel 10% recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Silatrix Oral Gel Polymerized Sucralfate Gel 10% (1 gm/10 gm
Recalling firm
SA3, LLC
Quantity
156 units
Distribution
U.S. Nationwide distribution in the states of CA, FL and GA.
Recall date
April 13, 2022
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls