Drug recall D-0347-2024

Class II Terminated reported Feb 28, 2024

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.

Lots and codes

Lot: 7001796, Exp 05/31/2025

Recall details

Recalling firm
MCKESSON CORPORATION, IRVING, TX
Quantity
42 units
Distribution
Nationwide in the US
Type
Voluntary: Firm initiated
Recall initiated
February 12, 2024
Terminated
October 1, 2024

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