Product: NYSTATIN 5BU, 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 51552-0041-5 Bar code 3 51552 00415 3
Reason for recall: Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
Recall initiated: 20231211
Status: Ongoing
Classification: Class II
Recall type: Voluntary: Firm initiated