Class IITerminated

CABTREO (clindamycin phosphate recall

FDA recall D-0347-2024 · initiated Feb 12, 2024

May cause temporary or medically reversible harm; low probability of serious harm.

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.

Details

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.
Recalling company: MCKESSON CORPORATION
Classification: Class II
Status: Terminated
Type: Voluntary: Firm initiated
Distribution: Nationwide in the US
Initiated: Feb 12, 2024
FDA report date: Feb 28, 2024

This recall is linked to a product we cover: Cabtreo →

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0347-2024 ↗

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