Class II
Ongoing
NYSTATIN 500 MU, 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 51552-0041-3, Bar code 3 51552 00413 9
This recall is currently active, issued December 27, 2023. It was issued by Fagron, Inc.
- Company
- Fagron, Inc
- Recall Initiated
- December 11, 2023
- Posted
- December 27, 2023
- Recall Number
- D-0155-2024
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 46 containers
- Firm Location
- Saint Paul, MN, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
Distribution
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 / Code Info
Lot #: 230308-U46225, Exp. date 04/30/2025, 221031-U42110, Exp. date 04/30/2025
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