Class II · Moderate risk Ongoing
Nystatin Cream USP
Reason Subpotent Drug: Low out of specification assay results performed during long-term stability testing.
Nystatin Oral Suspension
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
What was recalled
Nystatin Oral Suspension, USP 100,000 units per mL, a) 2 fl. oz. (60 mL), 24 bottles per case (NDC 66689-008-02), b) 16 fl. oz. (237 mL), 12 bottles per case (NDC 66689-008-16), Rx only, Manufactured by VistaPharm, Largo, FL 33771
- Recalling firm
- VistaPharm, Inc.
- NDC code
- 66689-008-02
- Origin
- FL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0457-2017
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.
Other Nystatin recalls
See all
Class II · Moderate risk Ongoing
Nystatin 150 Mu
Reason Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
Class II · Moderate risk Ongoing
Nystatin 2 Bu
Reason Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
Class II · Moderate risk Ongoing
Nystatin 500 Mu
Reason Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
Class II · Moderate risk Ongoing
Nystatin 5bu
Reason Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
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