D-0347-2024 Class II Terminated
FDA drug recall D-0347-2024 was initiated by MCKESSON CORPORATION on February 12, 2024 and is designated Class II. 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. The recall status is terminated (terminated October 1, 2024). Affected quantity: 42 units.
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