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

Recall Number: D-0156-2024

Firm: Fagron, Inc

Classification: Class II

Status: Ongoing

Report Date: 20231227

Initiation Date: 20231211

Termination Date:

Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.

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