🔍 RecallPedia

Lidocaine HCl / Oxymetazoline HCl Nasal Solution, 4% / 0.05%, 240mL per bottle, Multiple Dose Container for Intranasal Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1256-01, packaged in bottles. no label

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

What Should You Do?

  1. Check if you have this product:
    06-2021-18@3 12-15-2021 07/07/21 - 07/22/21 06-2021-30@10 12-27-2021 07/20/21 - 08/17/21 07-2021-14@4 01-10-2022 08/05/21 - 08/20/21 07-2021-21@4 01-17-2022 08/23/21 - 09/16/21, 07-2021-28@9 01-24-2022 09/13/21 - 10/05/21 08-2021-12@8 02-08-2022 10/01/21 - 10/19/21 08-2021-24@9 02-20-2022 10/19/21 - 11/11/21 09-2021-09@10 03-08-2022 11/10/21 - 11/30/21 10-2021-05@6 04-03-2022 11/30/21
  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:

Lidocaine HCl / Oxymetazoline HCl Nasal Solution, 4% / 0.05%, 240mL per bottle, Multiple Dose Container for Intranasal Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1256-01, packaged in bottles. no label

Product Codes/Lot Numbers:

06-2021-18@3 12-15-2021 07/07/21 - 07/22/21 06-2021-30@10 12-27-2021 07/20/21 - 08/17/21 07-2021-14@4 01-10-2022 08/05/21 - 08/20/21 07-2021-21@4 01-17-2022 08/23/21 - 09/16/21, 07-2021-28@9 01-24-2022 09/13/21 - 10/05/21 08-2021-12@8 02-08-2022 10/01/21 - 10/19/21 08-2021-24@9 02-20-2022 10/19/21 - 11/11/21 09-2021-09@10 03-08-2022 11/10/21 - 11/30/21 10-2021-05@6 04-03-2022 11/30/21

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-0438-2022

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