FDA Drug recall D-0443-2022
Phenol, Topical Solution (PF) Multiple Dose Vial, 89%, 3 mL per vial, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT, NDC 05446-1211-03
- FDA Drug
- Class II
- terminated
- Published 2022-02-02
On 2022-02-02 the FDA classified a Class II recall of Phenol, Topical Solution (PF) Multiple Dose Vial, 89%, 3 mL per vial, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT, NDC 05446-1211-03 by Edge Pharma, citing CGMP Deviations.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0443-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-12-06 |
| Published | 2022-02-02 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Edge Pharma |
| Distribution | US |
Product
Phenol, Topical Solution (PF) Multiple Dose Vial, 89%, 3 mL per vial, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT, NDC 05446-1211-03
Reason
CGMP Deviations
Identifiers
| code_info | 07-2021-12@9 01-08-2022 07/22/21 - 08/11/21 08-2021-11@10 02-07-2022 08/25/21 - 09/10/21 08-2021-12@12 02-08-2022 09/07…07-2021-12@9 01-08-2022 07/22/21 - 08/11/21 08-2021-11@10 02-07-2022 08/25/21 - 09/10/21 08-2021-12@12 02-08-2022 09/07/21 - 10/06/21 09-2021-22@5 03-21-2022 10/12/21 - 10/28/21 10-2021-07@8 04-05-2022 10/25/21 - 10/28/21 10-2021-08@4 04-06-2022 10/28/21 - 11/12/21 11-2021-01@7 04-30-2022 11/15/21 - 12/01/21 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0443-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.