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FDARecalled Dec 27, 2023 · #D-0157-2024

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 5...

Hazard

Class II — temporary health risk

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Description

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

Product details

Product
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
Type
Drugs
Manufacturer
Fagron, Inc
Model numbers
221031-U42104
UPCs