DrugDec 27, 2023
Fagron NYSTATIN 5BU, Activity (as is): 6482 Units/mg, bulk powder container recall — FDA D-0154-2024
Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
Class IIFDA: OngoingFagron, Inc.
Recall history in this database
Classification mix: Class II: 4.
DrugDec 27, 2023
Fagron NYSTATIN 500 MU, Activity (as is): 6482 Units/mg, bulk powder container recall — FDA D-0155-2024
Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
Class IIFDA: OngoingFagron, Inc.
DrugDec 27, 2023
Fagron NYSTATIN 2 BU, Activity (as is): 6482 Units/mg, bulk powder container recall — FDA D-0156-2024
Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
Class IIFDA: OngoingFagron, Inc.
DrugDec 27, 2023
Fagron NYSTATIN 150 MU, Activity (as is): 6482 Units/mg, bulk powder container recall — FDA D-0157-2024
Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
Class IIFDA: OngoingFagron, Inc.
Understanding this recall history
This page summarizes recall records in which the official source identifies Fagron, Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.