Tetracaine HCl Nasal Solution, 4%, 240 mL per bottle, Multiple Dose Container for Intranasal Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT, 05446, NDC 05446-1195-03, packaged in bottles.

Class I - Dangerous
💊 Drugs Recalled: December 6, 2021 Edge Pharma Other Drugs Nationwide

What Should You Do?

  1. Check if you have this product:
    06-2021-08@5 12-05-2021, 07-2021-07@7 01-03-2022, 07-2021-27@10 01-23-2022 & 10-2021-06@12 04-04-2022
  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:
Edge Pharma, LLC
Reason for Recall:
CGMP Deviations
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Tetracaine HCl Nasal Solution, 4%, 240 mL per bottle, Multiple Dose Container for Intranasal Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT, 05446, NDC 05446-1195-03, packaged in bottles.

Product Codes/Lot Numbers:

06-2021-08@5 12-05-2021, 07-2021-07@7 01-03-2022, 07-2021-27@10 01-23-2022 & 10-2021-06@12 04-04-2022

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-0447-2022

Related Recalls