Profound-PE Dental Gel, Lidocaine HCl/Prilocaine HCl/Tetracaine HCl/Phenylephrine, 10% / 10% / 4% / 2%, Spear-Peppermint, Multiple Dose Container for Topical Oral Use, 30 grams per jar, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT, 05446, NDC 05446-0408-10
Class I - DangerousWhat Should You Do?
- Check if you have this product: 07-2021-13@7 01-09-2022 08/24/21 - 10/06/21 07-2021-27@8 01-23-2022 10/06/21 - 11/02/21 08-2021-10@5 02-01-2022 10/28/21 - 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-PE Dental Gel, Lidocaine HCl/Prilocaine HCl/Tetracaine HCl/Phenylephrine, 10% / 10% / 4% / 2%, Spear-Peppermint, Multiple Dose Container for Topical Oral Use, 30 grams per jar, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT, 05446, NDC 05446-0408-10
Product Codes/Lot Numbers:
07-2021-13@7 01-09-2022 08/24/21 - 10/06/21 07-2021-27@8 01-23-2022 10/06/21 - 11/02/21 08-2021-10@5 02-01-2022 10/28/21 - 12/01/21
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-0442-2022
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