Profound Dental Gel Recalled for CGMP Manufacturing Deviations
Edge Pharma, LLC is recalling 221 jars of Profound Dental Gel (Lidocaine/Prilocaine/Tetracaine 10%/10%/4%) nationwide due to Good Manufacturing Practice (CGMP) deviations identified during production.
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 involving CGMP deviations with no reported illnesses or injuries stated in the source text. The hazard is manufacturing-process-related rather than acute harm, qualifying it as a moderate precautionary recall.
Plain-English summary
Edge Pharma, LLC is voluntarily recalling Profound Dental Gel, a topical oral anesthetic containing Lidocaine HCl 10%, Prilocaine HCl 10%, and Tetracaine HCl 4% in Spearmint-Peppermint flavor. The product is supplied in multiple-dose containers (NDC 05446-0407-10) and distributed nationwide.
The recall was initiated on December 6, 2021, following the identification of Current Good Manufacturing Practice (CGMP) deviations in the manufacturing process. A total of 221 jars have been affected. The FDA classified this as a Class II recall on January 24, 2022, and the recall was reported to the public on February 2, 2022.
Affected product batches include: 08-2021-16 (distributed 09/21/21–10/19/21), 09-2021-13 (distributed 11/04/21–11/17/21), 09-2021-29 (distributed 10/18/21–11/11/21), and 10-2021-26 (distributed 11/17/21–12/01/21).
Consumers should stop using the recalled product and contact their healthcare provider or pharmacy. The recall was terminated on June 7, 2023.
The recalled product
- Product
- 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
- Manufacturer
- Edge Pharma, LLC
- Affected units
- 221
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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