The Recall Desk
ModerateFDA (Drugs)·D-0439-2022·Announced 2022-02-02

Drug Recall: Profound Dental Gel CGMP Deviations

Edge Pharma is voluntarily recalling 353 jars of Profound Dental Gel nationwide due to Current Good Manufacturing Practice (CGMP) deviations identified during the manufacturing process.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall initiated voluntarily by the manufacturer due to CGMP deviations. The source text does not report any illness or injury cases, and the recall is precautionary in nature to address manufacturing process deviations rather than a confirmed contamination or safety hazard.

Plain-English summary

Edge Pharma, LLC is recalling Profound Dental Gel (Lidocaine HCl/Prilocaine HCl/Tetracaine HCl, 10%/10%/4%, Raspberry Marshmallow flavor, 30-gram jars) with NDC 05446-0790-10. The recall affects 353 jars that were distributed nationwide.

The firm initiated this voluntary recall on December 6, 2021, following the identification of Current Good Manufacturing Practice (CGMP) deviations during the manufacturing process. The FDA classified this recall as Class II on January 24, 2022.

Affected lot codes include: 07-2021-20@7 (with expiration date 01-16-2022), 08-2021-11@6 (02-07-2022), 08-2021-31@11 (02-01-2022), 09-2021-14@11 (02-01-2022), 09-2021-21@6 (02-01-2022), and 10-2021-12@4 (04-10-2022). Consumers who have purchased this product should stop using it and contact Edge Pharma for further instructions. The recall was terminated on June 7, 2023.

The recalled product

Product
Profound Dental Gel, Lidocaine HCl/Prilocaine HCl/Tetracaine HCl, 10%/10%/4% Raspberry Marshmallow, 30 grams per jar, Multiple Dose Container For Topical Oral Use,Edge Pharma LLC, 856 Hercules Dr. Colchester, VT 05446, NDC 05446-0790-10
Manufacturer
Edge Pharma, LLC
Category
Drug — Topical Oral Anesthetic
Hazard
  • cgmp-deviation
  • manufacturing-defect

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (5)

  • 07-2021-20@7 01-16-2022
  • 08-2021-11@6 02-07-2022
  • 08-2021-31@11 02-01-2022
  • 09-2021-14@11 02-01-2022
  • 09-2021-21@6 02-01-2022 & 10-2021-12@4 04-10-2022.

Distribution

Distributed nationwide across the United States.

Related recalls

Same category