CABTREO (clindamycin phosphate, adapalene and benzoyl peroxide) Topical Gel 1.2%/0.15%/3.1%, Not for Oral, Ophthalmic or
Summary
The FDA issued a Class II for CABTREO (clindamycin phosphate, adapalene and benzoyl peroxide) Topical Gel 1.2% by MCKESSON CORPORATION. Reason: CGMP Deviations: Product was stored outside labeled storage temperature requirements. Product was exposed to controlled room temperature environment i.
Details
Source
Drug Recall
External ID
D-0347-2024
Action Date
2024-02-28
Status
Terminated
Category
drug
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/Code Info: Lot: 7001796, Exp 05/31/2025
Quantity Affected: 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.
Distribution
Nationwide in the US
Type: Voluntary: Firm initiated
Recall Initiated: 2024-02-12
Company
IRVING, TX
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 41 drug recalls issued in the same week, part of 272 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (MCKESSON CORPORATION) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does MCKESSON CORPORATION have FDA actions?
This is the only FDA action we have on record for MCKESSON CORPORATION in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0347-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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