FDAFDA · Food and drugs·Recall number D-1378-2020
Nystatin Oral Suspension, USP 100,000 units per mL, Bubblegum Flavored, 16 fl. oz. bottle (480 mL), Shake Well Before Using, Rx Only, Manufactured by: VistaPharm, Inc., Largo, FL 33771, NDC 66689-008-16.
Published July 15, 2020 · Recall initiated: June 23, 2020
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 products; Presence of an impurity peak that exceeds the approved specification.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- VistaPharm, Inc.
- Distributor
- United States including Puerto Rico
- Lot
- Lot # 639000, Exp. 10/31/2021
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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