🔍 RecallPedia

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

Class I - Dangerous
🏥 Medical Devices Recalled: February 21, 2022 SA3 Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    Product Number: 69420-8351-1 Lot Number: U701SF1 UDI Code: N/A
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
SA3, LLC
Reason for Recall:
Due to failure of microbial testing for total aerobic microbial count (TAMC).
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

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

Product Codes/Lot Numbers:

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

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0856-2022