Cabtreo Gel
FDA Recall NDC 0187-0006
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Cabtreo (NDC 0187-0006). A significant event, classified as Class II, was initiated on Feb 12, 2024 by Bausch Health Us Llc. The reported reason for this action was: "CGMP Deviations: Product was stored outside labeled storage temperature requirements. Product was exposed to controlled room temperature environment instead of remaining refrigerated."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
CGMP Deviations: Product was stored outside labeled storage temperature requirements. Product was exposed to controlled room temperature environment instead of remaining refrigerated.
Feb 12, 2024
Feb 28, 2024
42 units
Recall Profile & Regulatory Data
Event ID
94023
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
MCKESSON CORPORATION
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the US
Termination Date
Oct 01, 2024
Product Description
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.
Batch or Lot Expiration Information
Lot# Lot: 7001796, Exp 05/31/2025
Affected Packages Involved in this Recall
0187-0006-10Product
0187-0006-25Product
0187-0006-35Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
