Fagron, Inc recalls NYSTATIN 5BU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For Prescription Compounding, Fagron, In
Recalled December 27, 2023 · FDA recall D-0154-2024 · Fagron
Hazard
Labeling: Label Error on Declared Strength: Assay value on the label is incorrect. · FDA Class II
Units
13 containers
Sold at
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.
Description
Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
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
Manufacturer(s)
Fagron, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →