DESOXIMETASONE Recall D-0676-2022
Description: Desoximetasone Ointment USP, 0.05%, Net Wt. 100 grams tubes, Rx only, Manufactured for: SOLA Pharmaceuticals, Baton Rouge, LA 70810, NDC 70512-037-10.
DESOXIMETASONE Recall D-0676-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0676-2022 |
| Event ID | 89798 |
| Brand | DESOXIMETASONE OINT 0.05% |
| Generic Name | DESOXIMETASONE OINT 0.05% |
| Manufacturer | DESOXIMETASONE OINT 0.05% |
| Original Package? | 1 |
| Active Substance | DESOXIMETASONE |
| Drug Route | TOPICAL |
| Distribution | Nationwide in the USA and Puerto Rico |
| Quantity | 6850 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 | 70512-037 |
| Product NUI | N0000175576 N0000175450 |
| Drug UPC | 0370512037109 0370512037604 |
| 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 | ANDA209973 |
| Structured Product Labeling (SPL ID) | a3e48b6e-4bd6-330d-e053-2995a90a75fe |
| Structured Product Labeling (SPL Set ID) | a3e48b6e-4bd5-330d-e053-2995a90a75fe |
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