D-0347-2024 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- February 28, 2024
- Initiation Date
- February 12, 2024
- Termination Date
- October 1, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 42 units
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.
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 Pattern
Nationwide in the US
Code Information
Lot: 7001796, Exp 05/31/2025