FDA recall D-0155-2024

Fagron, Inc · Class II · drug

Product

NYSTATIN 500 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 51552-0041-3, Bar code 3 51552 00413 9

Reason for recall

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

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.

Key facts

Status
Ongoing
Initiation date
2023-12-11
Report date
2023-12-27
Voluntary/Mandated
Voluntary: Firm initiated
Location
Saint Paul, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0155-2024