FDA Drug recall D-0684-2022
Fluocinonide Gel USP, 0.05%, packaged in a) 15 g tubes, NDC 52565-054-15
- FDA Drug
- Class II
- terminated
- Published 2022-03-30
On 2022-03-30 the FDA classified a Class II recall of Fluocinonide Gel USP, 0.05%, packaged in a) 15 g tubes, NDC 52565-054-15 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-0684-2022 |
| 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 Gel USP, 0.05%, packaged in a) 15 g tubes, NDC 52565-054-15; b) 60 g tubes, NDC 52565-054-60; c) 30 g tubes, NDC 52565-054-30, Rx Only, Teligent Pharma, Inc., Buena, NJ 08310.
Reason
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Identifiers
| code_info | Batch: a) 15122, Exp. 2/28/2022; 15475, Exp. 3/31/2022; b) 15119, Exp. 2/28/2022; 15122, Exp. 2/28/2022; 15380, Exp. 3/31/2022; c) 15380, Exp. 3/31/2022 |
|---|
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-0684-2022%22
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