Drug recall: CABTREO topical gel stored at improper temperature
CABTREO acne medication was stored outside refrigeration requirements. The recalled lot was kept at room temperature instead of required refrigerated conditions.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II drug recall with no reported illnesses or injuries. A CGMP deviation in storage conditions represents a risk-of-harm product without reported injury, meeting the criteria for a score of 3 per the rubric.
Plain-English summary
CABTREO (clindamycin phosphate, benzoyl peroxide, adapalene) 1.2%/0.15%/3.1% topical gel is being recalled by McKESSON CORPORATION and distributor Bausch Health US, LLC due to improper storage conditions.
The recalled product was stored at controlled room temperature instead of the required refrigerated conditions, a violation of Current Good Manufacturing Practice (CGMP) standards.
This recall affects 42 units of CABTREO with lot number 7001796 (expiration 05/31/2025) that were distributed nationwide in the United States. Consumers who have purchased this medication should consult their pharmacy or healthcare provider regarding the affected lot.
The recalled product
- Product
- CABTREO (CLINDAMYCIN PHOSPHATE/BENZOYL PEROXIDE/ADAPALENE)
- Brand
- CABTREO
- Manufacturer
- MCKESSON CORPORATION
- Category
- Drug — Topical Acne Treatment
- Hazard
- Affected units
- 42
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot: 7001796
- Exp 05/31/2025
Distribution
Distributed nationwide across the United States.
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