Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Presence of Foreign Substance: potential presence of plastic particles.
Nystatin Topical Powder, USP, 100,000 USP units per gram, 15 grams per bottle, Rx only, Vensun, NDC 42543-052-61
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 Subpotent Drug: Low out of specification assay results performed during long-term stability testing.
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.
Tell us which medications you take. If the FDA recalls one, we email you - in plain English, with what to do. Free.