FDARecalled Dec 27, 2023 · #D-0156-2024
NYSTATIN 2 BU, 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 51552-0041-4, Bar code 3 515...
Hazard
Class II — temporary health risk
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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 2 BU, 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 51552-0041-4, Bar code 3 51552 00414 6
- Type
- Drugs
- Manufacturer
- Fagron, Inc
- Model numbers
- 230308-U46224
- UPCs
- —