CABTREO — Class II drug recall D-0347-2024
Terminated recall by MCKESSON CORPORATION, reported 2024-02-28, distributed nationwide. CGMP Deviations: Product was stored outside labeled storage temperature requirements. Product was exposed to c
| Recall number | D-0347-2024 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | MCKESSON CORPORATION, IRVING, TX, United States |
| Recall initiated | 2024-02-12 |
| Classified | 2024-02-22 |
| Reported by FDA | 2024-02-28 |
| Terminated | 2024-10-01 |
| Distributed | Nationwide (US) |
| Quantity | 42 units |
| Reason classes | labeling, cgmp |
| NDC | 00187-0006, 00187-0006-10, 00187-0006-25, 00187-0006-35 |
| Lot numbers | 7001796 |
| Expiration dates | 2025-05-31 |
Product
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.
Reason for recall
CGMP Deviations: Product was stored outside labeled storage temperature requirements. Product was exposed to controlled room temperature environment instead of remaining refrigerated.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0347-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.