FDA-Drug2023-12-27Class II
NYSTATIN 150 MU, 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 51552-0041-1, Bar code 3 51552 00411 5
Fagron, Inc
Hazard
Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
Sold states
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.
Affected count
52 containers
Manufactured in
2400 Pilot Knob Rd, N/A, Saint Paul, MN, United States
Products
NYSTATIN 150 MU, 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 51552-0041-1, Bar code 3 51552 00411 5
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0157-2024Don't want to check this manually?
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