Recalls / Class II
Class IID-0347-2024
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.
- Brand name
- Cabtreo
- Generic name
- Clindamycin Phosphate/benzoyl Peroxide/adapalene
- Active ingredients
- Adapalene, Benzoyl Peroxide, Clindamycin Phosphate
- Route
- Topical
- NDC
- 0187-0006
- FDA application
- NDA216632
- Affected lot / code info
- Lot: 7001796, Exp 05/31/2025
Why it was recalled
CGMP Deviations: Product was stored outside labeled storage temperature requirements. Product was exposed to controlled room temperature environment instead of remaining refrigerated.
Recalling firm
- Firm
- MCKESSON CORPORATION
- Manufacturer
- Bausch Health US LLC
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 6555 NORTH STATE HIGHWA, N/A, IRVING, Texas 75039
Distribution
- Quantity
- 42 units
- Distribution pattern
- Nationwide in the US
Timeline
- Recall initiated
- 2024-02-12
- FDA classified
- 2024-02-22
- Posted by FDA
- 2024-02-28
- Terminated
- 2024-10-01
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0347-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.