Mckesson Medical-Surgical recalls Ketoconazole Cream 2% (60g) due to temperature abuse during storage. This prescription-only product may be unsafe if exposed to improper temperatures.
cGMP deviations: Temperature abuse
Mckesson Medical-Surgical is recalling prescription Ketoconazole Cream 2% (60g tubes) because of temperature abuse issues. This could lead to unsafe conditions if the product is stored improperly.
The product was manufactured under cGMP deviations related to temperature abuse. This means the cream may be unstable or unsafe if stored outside recommended temperature ranges, potentially causing ineffective treatment or adverse effects.
Prescription holders who received this specific cream from McKesson Medical-Surgical. Patients using the product without proper temperature control are at risk.
Check for the 60g tube labeled 'Ketoconazole Cream 2%, Rx only' with NDC 0168-0099-60. Products distributed by McKesson Medical-Surgical may have been affected if received after the specified dates.
Identify the product by checking the tube size (60g), label, and NDC number (0168-0099-60).
The recall indicates potential temperature abuse issues, but the official notice does not specify if the product is safe to use without proper temperature control.
Check for the 60g tube labeled 'Ketoconazole Cream 2%, Rx only' with NDC 0168-0099-60. Products distributed by McKesson Medical-Surgical may have been affected if received after the specified dates.
The recall does not specify a remedy, so the official notice does not provide instructions on what to do with the product.
We’ve drafted a message you can send Mckesson Medical-Surgical to request your refund or repair — edit it as you like.
Subject: Recall D-1065-2022 — Mckesson Medical-Surgical Mckesson Medical-Surgical Hello, I own a Mckesson Medical-Surgical that is covered by recall D-1065-2022 from Mckesson Medical-Surgical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
