Profound-PE Dental Gel, Lidocaine HCl/ Prilocaine HCl/ Tetracaine HCl/ Phenylephrin HCl, 10% / 10% / 4% / 2% Raspberry-Marshmallow, Multiple Dose Container for Topical Oral Use, Edge Pharma, LLC, 856 Hercules Dr. Colchester, VT NDC 05446-1018-10
Class I - DangerousWhat Should You Do?
- Check if you have this product: 06-2021-29@15 12-26-2021, 07-2021-12@7 01-08-2022, 08-2021-03@7 01-30-2022, 08-2021-25@5 02-01-2022, 09-2021-10@4 02-01-2022, 09-2021-22@6 03-01-2022 & 10-2021-06@11 04-04-2022
- 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/ Phenylephrin HCl, 10% / 10% / 4% / 2% Raspberry-Marshmallow, Multiple Dose Container for Topical Oral Use, Edge Pharma, LLC, 856 Hercules Dr. Colchester, VT NDC 05446-1018-10
Product Codes/Lot Numbers:
06-2021-29@15 12-26-2021, 07-2021-12@7 01-08-2022, 08-2021-03@7 01-30-2022, 08-2021-25@5 02-01-2022, 09-2021-10@4 02-01-2022, 09-2021-22@6 03-01-2022 & 10-2021-06@11 04-04-2022
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-0441-2022
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