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CABTREO (clindamycin phosphate, adapalene and benzoyl peroxide) Topical Gel 1.2%/0.15%/3.1%, Not ...

FDA Recall #D-0347-2024 — Class II — February 12, 2024

Recall #D-0347-2024 Date: February 12, 2024 Classification: Class II Status: Terminated

Product 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.

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.

Recalling Firm

MCKESSON CORPORATION — IRVING, TX

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

42 units

Distribution

Nationwide in the US

Code Information

Lot: 7001796, Exp 05/31/2025

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

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