Profound-pe Dental recalls
The FDA has published 2 recalls involving Profound-pe Dental since 2022. The latest was reported on 2 Feb 2022. Most were for manufacturing (cgmp) deviations. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.
Total recalls2since 2022
Last 12 months0reported
Class I00% of total
Ongoing0latest 2 Feb 2022
Recalls per month, last 24 months
click a bar for that monthSeverity split
Class I 0 0%Class II 2 100%Class III 0 0%
Why profound-pe dental is recalled
Companies
By year
All profound-pe dental recalls, newest first
2 total| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Profound-PE Dental Gel, Lidocaine HCl/ Prilocaine HCl recalled | Edge Pharma | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Profound-PE Dental Gel, Lidocaine HCl/Prilocaine recalled by Edge Pharma | Edge Pharma | Manufacturing (CGMP) Deviations | Nationwide |
Should you stop taking Profound-pe Dental?
Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.