FDA Drug recall D-0685-2022
Fluocinonide Topical Solution USP, 0.05%, packaged in a) 20 mL bottles, NDC 52565-025-20
- FDA Drug
- Class II
- terminated
- Published 2022-03-30
On 2022-03-30 the FDA classified a Class II recall of Fluocinonide Topical Solution USP, 0.05%, packaged in a) 20 mL bottles, NDC 52565-025-20 by Teligent Pharma, citing cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0685-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-03-15 |
| Published | 2022-03-30 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Teligent Pharma |
| Distribution | US |
Product
Fluocinonide Topical Solution USP, 0.05%, packaged in a) 20 mL bottles, NDC 52565-025-20; b) 60 mL bottles, NDC 52565-025-59, Rx only, Teligent Pharma, Inc., Buena, New Jersey 08310.
Reason
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Identifiers
| code_info | Batch: 17138, Exp. 2/28/2023 |
|---|
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-0685-2022%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.