Fagron, Inc: 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 c

Hazard

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

Details from the source

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. Quantity: 9 containers Lot/code info: Lot #: 230308-U46224, Exp. date 04/30/2025, 221031-U42105, Exp. date 04/30/2025

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.