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.
D-0347-2024
Product summary
- Event
- Event 94023
- Status
- Terminated
- Classification
- Class II
- Quantity
- 42 units
- Official record key
drug-enforcement:D-0347-2024
Official wording
Reason: CGMP Deviations: Product was stored outside labeled storage temperature requirements. Product was exposed to controlled room temperature environment instead of remaining refrigerated.
Code information: Lot: 7001796, Exp 05/31/2025
Distribution pattern: Nationwide in the US
Derived failure modes
-
Manufacturing or process control
CGMP Deviations