Recall D-0154-2024
Description: NYSTATIN 5BU, 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 51552-0041-5 Bar code 3 51552 00415 3
Recall D-0154-2024 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0154-2024 |
| Event ID | 93594 |
| 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. |
| Quantity | 13 containers |
| Recall Reason | Labeling: Label Error on Declared Strength: Assay value on the label is incorrect. |
| Drug Classification | Class II |
| Drug Code Info | 20231227 |
| Recall Initiation Date | 20231211 |
| Report Date | 20231227 |
| Classification Date | 20231221 |
| Address | 2400 Pilot Knob Rd Saint Paul, MN 55120-1118 United States |
| Recalling Firm | Fagron, Inc |
| Initial Notification | Letter |
| Similar To |