Drug 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
D-0157-2024
Product summary
- Firm
- Fagron, Inc
- Event
- Event 93594
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 52 containers
- Official record key
drug-enforcement:D-0157-2024
Official wording
Reason: Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
Code information: Lot #: 221031-U42104, Exp. date 04/30/2025
Distribution pattern: 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.
Derived failure modes
-
Labeling or packaging
Labeling: Label Error