FDA Drug recall D-0347-2024
CABTREO (clindamycin phosphate, adapalene and benzoyl peroxide) Topical Gel 1.2%/0.15%/3.1%, Not for Oral, Ophthalmic or Intravaginal Use,…
- FDA Drug
- Class II
- terminated
- Published 2024-02-28
On 2024-02-28 the FDA classified a Class II recall of CABTREO (clindamycin phosphate, adapalene and benzoyl peroxide) Topical Gel 1.2%/0.15%/3.1%, Not for Oral, Ophthalmic or Intravaginal Use,… by Mckesson, citing CGMP Deviations: Product was stored outside labeled storage temperature requirements. Product was exposed to controlled room temperature environment instead of remaining refrigera….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0347-2024 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2024-02-12 |
| Published | 2024-02-28 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Mckesson |
| Distribution | US |
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
CGMP Deviations: Product was stored outside labeled storage temperature requirements. Product was exposed to controlled room temperature environment instead of remaining refrigerated.
Identifiers
| ndc | 0187-0006-10 |
|---|---|
| ndc | 0187-0006-25 |
| ndc | 0187-0006-35 |
| code_info | Lot: 7001796, Exp 05/31/2025 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0347-2024%22
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