FDAFDA · Food and drugs·Recall number D-0156-2024
NYSTATIN 2 BU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For Prescription Compounding, Fagron, Inc. - 2400 Pilot Knob Rd. St Paul, MN 55120. NDC 51552-0041-4, Bar code 3 51552 00414 6
Published December 27, 2023 · Recall initiated: December 11, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Fagron, Inc
- Distributor
- Product was distributed to 1 distributor and may have further distributed the product to repacker/relabelers and pharmacies in the United States and Canada to be used for prescription compounding.
- Lot
- Lot #: 230308-U46224, Exp. date 04/30/2025, 221031-U42105, Exp. date 04/30/2025
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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