Profound-PE Dental Gel Recalled for Manufacturing Deviations
Edge Pharma, LLC is recalling Profound-PE Dental Gel nationwide due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects 175 jars of the topical oral anesthetic gel.
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: The FDA classified this as a Class II recall. The source text identifies only CGMP deviations as the reason—a manufacturing compliance issue—with no reported illnesses, injuries, or adverse events documented. This fits the "low-risk contamination" or process-deviation profile typical of Moderate severity.
Plain-English summary
Edge Pharma, LLC is recalling Profound-PE Dental Gel, a topical oral anesthetic containing Lidocaine HCl, Prilocaine HCl, Tetracaine HCl, and Phenylephrine. The product is a 30-gram multiple-dose container available in Spear-Peppermint flavor (NDC 05446-0408-10). The recall was initiated on December 6, 2021, following detection of Current Good Manufacturing Practice (CGMP) deviations in the product's manufacturing process.
A total of 175 jars were distributed nationwide. The affected products span multiple manufacturing batches with lot codes 07-2021-13@7, 07-2021-27@8, and 08-2021-10@5, manufactured between August 24, 2021, and December 1, 2021, and distributed between January 9, 2022, and February 1, 2022.
This is a voluntary, firm-initiated recall. Consumers and healthcare providers who have this product should stop using it. The recall was terminated on June 7, 2023.
The recalled product
- Product
- 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
- Manufacturer
- Edge Pharma, LLC
- Category
- Drug — Topical Oral Anesthetic
- Hazard
- cgmp-deviation
Distribution
Distributed nationwide across the United States.
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