The Recall Desk
ModerateFDA (Drugs)·D-1065-2022·Announced 2022-06-15

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.

What this means for you

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
Hazard
  • temperature-abuse
  • manufacturing-defect

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.

Related recalls

Same category