Edge Pharma, LLC: Drug Recall
Recall #D-0440-2022 · 12/06/2021
Class II: Risk
Recall Details
- Recall Number
- D-0440-2022
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- Edge Pharma, LLC
- Status
- Terminated
- Date Initiated
- 12/06/2021
- Location
- Colchester, VT, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 221 jars
Reason for Recall
CGMP Deviations
Product Description
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
Distribution Pattern
nationwide
Other Recalls by Edge Pharma, LLC
- Class II: Risk 12/06/2021
- Class II: Risk 12/06/2021
- Class II: Risk 12/06/2021
- Class II: Risk 12/06/2021
- Class II: Risk 12/06/2021
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.