Ketoconazole Cream 2% Recalled Due to Manufacturing Temperature Abuse
McKesson Medical-Surgical is recalling Ketoconazole Cream 2% (60-gram tubes) distributed nationwide due to cGMP deviations involving temperature abuse during manufacturing.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. The hazard—manufacturing temperature control deviations—is a manufacturing compliance issue rather than a direct safety threat.
Plain-English summary
McKesson Medical-Surgical Inc. is recalling Ketoconazole Cream 2% (NDC 0168-0099-60) in 60-gram tubes, manufactured by Nycomed Inc. The product was distributed nationwide throughout the USA.
The recall was initiated due to cGMP deviations involving temperature abuse during the manufacturing process.
Specific lot numbers cannot be identified by individual customers. McKesson Medical-Surgical included distribution dates and shipping information in recall notification letters to customers. Healthcare providers and patients with this product should contact their McKesson supplier for instructions regarding quarantine, return, and replacement.
The recalled product
- Product
- KETOCONAZOLE (KETOCONAZOLE)
- Brand
- KETOCONAZOLE
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Drug — Topical Antifungal
- Affected units
- 6
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
UPCs (1)
- 0301680099156
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 130 recalled by Mckesson Medical-Surgical Inc. Corporate Office under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 130 products in this recall →Related recalls
Same brand · KETOCONAZOLE
- LowFougera Recalls Ketoconazole Cream Due to Out-of-Specification Degradants
FDA (Drugs) · 2014-02-05
- LowFougera Recalls Ketoconazole Cream 2% Due to Unknown Degradant
FDA (Drugs) · 2013-04-10
Same manufacturer · Mckesson Medical-Surgical Inc. Corporate Office
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Same hazard · temperature abuse
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Similar recalls
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FDA (Drugs) · 2013-04-10
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