BETAMETHASONE DIPROPIONATE Recall D-0727-2022
Description: Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05%,15 g tubes, Rx only, Manufactured by: Taro Pharmaceuticals Industries Ltd. Haifa Bay, Israel 2624761, Distributed by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532, NDC 51672-4048-1
BETAMETHASONE DIPROPIONATE Recall D-0727-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0727-2022 |
| Event ID | 89678 |
| Brand | CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE |
| Generic Name | CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE |
| Manufacturer | CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE |
| Original Package? | 1 |
| Active Substance | BETAMETHASONE DIPROPIONATE CLOTRIMAZOLE |
| Drug Route | TOPICAL |
| Distribution | Product was distributed to one retail consignee in NY. |
| Quantity | 768 tubes |
| Recall Reason | Failed Content Uniformity Specifications: Out-of-specification result for the Betamethasone Dipropionate assay of a stability sample |
| Drug Classification | Class III |
| Drug Code Info | 20220406 |
| Product NDC | 51672-4048 |
| Product NUI | N0000175487 M0002083 |
| Pharma Class (EPC) | Azole Antifungal [EPC] |
| Pharma Class (CS) | Azoles [CS] |
| Recall Initiation Date | 20220225 |
| Report Date | 20220406 |
| Classification Date | 20220329 |
| Address | 3 Skyline Dr Hawthorne, NY 10532-2174 United States |
| Recalling Firm | Taro Pharmaceuticals U.S.A., Inc. |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 826Y60901U G07GZ97H65 |
| Drug Application Number | ANDA075673 |
| Structured Product Labeling (SPL ID) | 360f672f-0ae0-47b7-b71b-371a471a2060 |
| Structured Product Labeling (SPL Set ID) | 1c18e5fc-bf82-47bc-bfd9-8d3e503569ba |
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