DESOXIMETASONE Recall D-0678-2022
Description: Desoximetasone Ointment USP, 0.25%, packaged in a) 100 grams tubes, NDC 52565-030-99; b) 60 grams tubes, NDC 52565-030-60; c) 15 grams tubes, NDC 52565-030-15, Rx Only, Teligent Pharma, Inc., Buena, New Jersey 08310.
DESOXIMETASONE Recall D-0678-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0678-2022 |
| Event ID | 89798 |
| Brand | DESOXIMETASONE |
| Generic Name | DESOXIMETASONE |
| Manufacturer | DESOXIMETASONE |
| Original Package? | 1 |
| Active Substance | DESOXIMETASONE |
| Drug Route | TOPICAL |
| Distribution | Nationwide in the USA and Puerto Rico |
| Quantity | 13,989 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 | 52565-030 |
| 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 | 4E07GXB7AU |
| Drug Application Number | ANDA208101 |
| Structured Product Labeling (SPL ID) | 02ded2db-0bf5-4b55-a8c7-19d06486c689 |
| Structured Product Labeling (SPL Set ID) | 53d8d9ed-5749-4874-a345-be768c8a0e59 |
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