Fagron, Inc: Drug Recall
Recall #D-0157-2024 · 12/11/2023
Class II: Risk
Recall Details
- Recall Number
- D-0157-2024
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- Fagron, Inc
- Status
- Ongoing
- Date Initiated
- 12/11/2023
- Location
- Saint Paul, MN, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 52 containers
Reason for Recall
Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
Product Description
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
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.
Other Recalls by Fagron, Inc
- Class II: Risk 12/11/2023
- Class II: Risk 12/11/2023
- Class II: Risk 12/11/2023
- Class III: Low Risk 03/04/2022
- Class III: Low Risk 03/04/2022
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.