FDAFDA · Food and drugs·Recall number D-0869-2017
Nystatin Oral Suspension, USP, 100,000 units/mL, packaged in a) 2 fl.oz. (60mL) bottles (NDC 66689-008-02), and 500,000 units/5mL individual unit dose cup (NDC 66689-037-01) packaged in b) 50 count unit dose cups/case (NDC 66689-037-50) and c) 100 count unit dose cups/case (NDC 66689-037-99) Rx only, Manufactured by: VistaPharm, Largo, FL 33771.
Published June 7, 2017 · Recall initiated: May 17, 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
Failed Impurities/Degradation Specifications: Presence of an impurity peak that exceeds approved specification.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- VistaPharm, Inc.
- Distributor
- Nationwide in the US and Puerto Rico
- Lot
- a) Lot #: 431300, Exp. 01/2018; b) Lot #: 434000, 432500, Exp. 07/2017;462200, Exp. 02/2018 c) Lot #: 443800, 445500, Exp. 09/2017; 460500, 461500, Exp. 01/2018.
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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