Recall: D-1065-2022

Class II - Potentially Harmful

Class IIClassification

2022-04-13Initiated

TerminatedStatus

Mckesson Medical-Surgical Inc.Firm

Product

Ketoconazole Cream, 2%, Net Wt 60 grams tube, Rx only, MFG: Nycomed Inc, NDC 0168-0099-60

Reason

cGMP deviations: Temperature abuse

Distribution

USA nationwide.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.