NYSTATIN 2 BU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For Prescription ...
FDA Recall #D-0156-2024 — Class II — December 11, 2023
Product Description
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
Reason for Recall
Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
Recalling Firm
Fagron, Inc — Saint Paul, MN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
9 containers
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.
Code Information
Lot #: 230308-U46224, Exp. date 04/30/2025, 221031-U42105, Exp. date 04/30/2025
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated