FDA recall D-0347-2024

MCKESSON CORPORATION · Class II · drug

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.

Distribution

Nationwide in the US

Key facts

Status
Terminated
Initiation date
2024-02-12
Report date
2024-02-28
Termination date
2024-10-01
Voluntary/Mandated
Voluntary: Firm initiated
Location
IRVING, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0347-2024