US Drug Recall Register
Class II · Moderate risk Terminated Initiated Feb 12, 2024 (3 years ago)

CABTREO (clindamycin phosphate, adapalene and benzoyl peroxide) Topical Gel…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

CGMP Deviations: Product was stored outside labeled storage temperature requirements. Product was exposed to controlled room temperature environment instead of remaining refrigerated.

What was recalled

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.

Recalling firm
Mckesson Corporation
NDC code
0187-0006-25
Origin
TX, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0347-2024

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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