ADAPALENE Recall D-0347-2024
Description: CABTREO (clindamycin phosphate, adapalene and benzoyl peroxide) Topical Gel 1.2%/0.15%/3.1%, Not for Oral, Ophthalmic or Intravaginal Use, Rx Only, Net Wt. 50g, Distributed by Bausch Health US, LLC Bridgewater, NJ 08807 USA, Manufactured by: Bausch Health Companies, Inc. Laval Quebec H7L 448, Canada, NDC 0187-0006-25.
ADAPALENE Recall D-0347-2024 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0347-2024 |
| Event ID | 94023 |
| Brand | CABTREO |
| Generic Name | CLINDAMYCIN PHOSPHATE/BENZOYL PEROXIDE/ADAPALENE |
| Manufacturer | CLINDAMYCIN PHOSPHATE/BENZOYL PEROXIDE/ADAPALENE |
| Original Package? | 1 |
| Active Substance | ADAPALENE BENZOYL PEROXIDE |
| Drug Route | TOPICAL |
| Distribution | Nationwide in the US |
| Quantity | 42 units |
| Recall Reason | CGMP Deviations: Product was stored outside labeled storage temperature requirements. Product was exposed to controlled room temperature environment instead of remaining refrigerated. |
| Drug Classification | Class II |
| Drug Code Info | 20240228 |
| Product NDC | 0187-0006 |
| Product NUI | N0000175607 M0018962 |
| Pharma Class (EPC) | Retinoid [EPC] |
| Pharma Class (CS) | Retinoids [CS] |
| Recall Initiation Date | 20240212 |
| Report Date | 20240228 |
| Classification Date | 20240222 |
| Address | 6555 NORTH STATE HIGHWA IRVING, TX 75039 United States |
| Recalling Firm | MCKESSON CORPORATION |
| Initial Notification | |
| Unique Ingredient Identifier | 1L4806J2QF W9WZN9A0GM |
| Drug Application Number | NDA216632 |
| Structured Product Labeling (SPL ID) | 0990acf9-6777-a127-e063-6294a90a3c93 |
| Structured Product Labeling (SPL Set ID) | 9468da0f-9978-4c58-8135-0274c3415084 |
| Similar To |