FDAFDA · Food and drugs·Recall number D-0457-2017
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
Published February 8, 2017 · Recall initiated: January 18, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- VistaPharm, Inc.
- Distributor
- Nationwide
- Lot
- a) Lot No. 422600 (Exp. 10/17), 420000 (Exp. 09/17), 416100 (Exp. 08/17), 417400 (Exp. 09/17) b) Lot No. 424200 (Exp. 10/17), 415500 (Exp. 03/18)
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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