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
- Affected units
- 353
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.
Part of a larger recall action
This product is one of 56 recalled by Edge Pharma, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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