# FDA recall D-0347-2024

> **MCKESSON CORPORATION** · Class II · drug recall initiated 2024-02-12.

## 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.

## Distribution

Nationwide in the US

## Key facts

- **Recall number:** D-0347-2024
- **Recalling firm:** MCKESSON CORPORATION
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2024-02-12
- **Report date:** 2024-02-28
- **Termination date:** 2024-10-01

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** IRVING, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0347-2024

## Citation

> AI Analytics. FDA recall D-0347-2024. Retrieved 2026-07-06 from https://api.ai-analytics.org/recall/D-0347-2024. Source: US FDA. Licensed CC0.

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