Fagron, Inc recalls NYSTATIN 5BU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For Prescription Compounding, Fagron, In…

Recall date

December 11, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0154-2024

FDA classification

Class II

Brand / firm

Fagron, Inc

Sold / distributed

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.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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