FDAFDA · Food and drugs·Recall number D-0019-2021
NYSTATIN ORAL SUSPENSION, USP 100,000 units per mL Contains: Alcohol 0.5% v/v (Bubblegum Flavored) 16 fl. oz. (480 mL) Manufactured by: VistaPharm, Inc. Largo FL 33771, USA NDC 66689-008-16 UPC 6668900816,
Published October 14, 2020 · Recall initiated: September 25, 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 Impurties/Degradation Specifications: out of specification results for an impurity for one lot
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- VistaPharm, Inc.
- Distributor
- Distributed Nationwide in the USA including Puerto Rico
- Lot
- Lots: 638800 Exp 10/21
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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