Product Safety Recalls

Product Recall Tracker

Recall D-0155-2024

Description: 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

Recall D-0155-2024 Information

Mandated?Voluntary: Firm initiated
Recall NumberD-0155-2024
Event ID93594
DistributionProduct 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.
Quantity46 containers
Recall ReasonLabeling: Label Error on Declared Strength: Assay value on the label is incorrect.
Drug ClassificationClass II
Drug Code Info20231227
Recall Initiation Date20231211
Report Date20231227
Classification Date20231221
Address2400 Pilot Knob Rd
Saint Paul, MN 55120-1118
United States
Recalling FirmFagron, Inc
Initial Notification Letter
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