Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Subpotent Drug: Low out of specification assay results performed during long-term stability testing.
Nystatin Cream USP, (100,000 USP Nystatin Units), NET WT 15 g, Rx only, 15 g tube, Manufactured by Padagis, Yeruham, Israel, NDC 45802-059-35
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
Reason Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
Reason Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
Reason Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
Reason cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Tell us which medications you take. If the FDA recalls one, we email you - in plain English, with what to do. Free.