Status
Terminated
Drug Enforcement D-0347-2024
CGMP Deviations: Product was stored outside labeled storage temperature requirements. Product was exposed to controlled room temperature environment instead of remaining refrigerated.
Classification
Class II
Report Date
February 28, 2024
Termination Date
October 1, 2024
Product Information
- 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.
- Product quantity
- 42 units
- 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.
- Recall initiation reason
- —
- Initial firm notification
- Distribution pattern
- Nationwide in the US
Location & Firm
- Recalling firm
- MCKESSON CORPORATION
- Address
-
6555 NORTH STATE HIGHWA, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0347-2024
- Event ID
- 94023
- Recall initiation date
- February 12, 2024
- Center classification date
- February 22, 2024
- Code info
- Lot: 7001796, Exp 05/31/2025
- More code info
- —