FLUOCINONIDE Recall D-0684-2022
Description: 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.
FLUOCINONIDE Recall D-0684-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0684-2022 |
| Event ID | 89798 |
| Brand | FLUOCINONIDE |
| Generic Name | FLUOCINONIDE |
| Manufacturer | FLUOCINONIDE |
| Original Package? | 1 |
| Active Substance | FLUOCINONIDE |
| Drug Route | TOPICAL |
| Distribution | Nationwide in the USA and Puerto Rico |
| Quantity | 51,748 tubes |
| Recall Reason | cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. |
| Drug Classification | Class II |
| Drug Code Info | 20220330 |
| Product NDC | 52565-054 |
| Product NUI | N0000175576 N0000175450 |
| Pharma Class (EPC) | Corticosteroid [EPC] |
| Recall Initiation Date | 20220315 |
| Report Date | 20220330 |
| Classification Date | 20220321 |
| Address | 105 Lincoln Avenue Buena, NJ 08310 United States |
| Recalling Firm | Teligent Pharma, Inc. |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 2W4A77YPAN |
| Drug Application Number | ANDA209030 |
| Structured Product Labeling (SPL ID) | 531184f7-770c-46a4-9bfa-3dbf2a575aa6 |
| Structured Product Labeling (SPL Set ID) | 2aa35781-40e0-7ce9-45fa-f97333f29085 |
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