Profound Dental Gel, Lidocaine HCl/Prilocaine HCl/Tetracaine HCl, 10% / 10% / 4%, Spearmint-Peppermint, Multiple Dose Container for Topical Oral Use, Edge Pharma, LLC, 856 Hercules Dr. Colchester, VT NDC 05446-0407-10
Class I - DangerousWhat Should You Do?
- Check if you have this product: 08-2021-16@12 02-01-2022 09/21/21 - 10/19/21 09-2021-13@8 02-01-2022 11/04/21 - 11/17/21 09-2021-29@8 03-01-2022 10/18/21 - 11/11/21 10-2021-26@7 04-24-2022 11/17/21 - 12/01/21
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- 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:
Profound Dental Gel, Lidocaine HCl/Prilocaine HCl/Tetracaine HCl, 10% / 10% / 4%, Spearmint-Peppermint, Multiple Dose Container for Topical Oral Use, Edge Pharma, LLC, 856 Hercules Dr. Colchester, VT NDC 05446-0407-10
Product Codes/Lot Numbers:
08-2021-16@12 02-01-2022 09/21/21 - 10/19/21 09-2021-13@8 02-01-2022 11/04/21 - 11/17/21 09-2021-29@8 03-01-2022 10/18/21 - 11/11/21 10-2021-26@7 04-24-2022 11/17/21 - 12/01/21
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-0440-2022
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