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.
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.
Lot numbers, UPCs & expiration codes
Lot: 7001796, Exp 05/31/2025
Where it was sold
Nationwide in the US
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0347-2024
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 12, 2024
- FDA report date
- Feb 28, 2024
- Quantity
- 42 units
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- MCKESSON CORPORATION
Original FDA data
Every field from FDA enforcement report D-0347-2024, exactly as published.
Show all FDA fields
- City
- IRVING
- State
- TX
- Status
- Terminated
- Country
- United States
- Event ID
- 94023
- Address
- 6555 NORTH STATE HIGHWA
- Code information
- Lot: 7001796, Exp 05/31/2025
- Postal code
- 75039
- Report date
- Feb 28, 2024
- Product type
- Drugs
- Recall number
- D-0347-2024
- Classification
- Class II
- Recalling firm
- MCKESSON CORPORATION
- Product quantity
- 42 units
- Termination date
- Oct 1, 2024
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide in the US
- Recall initiation date
- Feb 12, 2024
- Initial firm notification
- Center classification date
- Feb 22, 2024