FDAFDA · Food and drugs·Recall number Z-0856-2022
Silatrix Oral Gel Polymerized Sucralfate Gel 10% (1 gm/10 gm
Published April 13, 2022 · Recall initiated: February 21, 2022
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Due to failure of microbial testing for total aerobic microbial count (TAMC).
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- SA3, LLC
- Distributor
- U.S. Nationwide distribution in the states of CA, FL and GA.
- Lot
- Product Number: 69420-8351-1 Lot Number: U701SF1 UDI Code: N/A
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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