CABTREO Topical Gel 1 recalled over manufacturing violations

Recall date

February 12, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

MCKESSON CORPORATION recalls CABTREO (clindamycin phosphate, adapalene and benzoyl peroxide) Topical Gel 1.2%/0.15%/3.1%, Not for Oral, Ophthalmic o…

Recall number

D-0347-2024

FDA classification

Class II

Brand / firm

MCKESSON CORPORATION

Sold / distributed

Nationwide in the US

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

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.