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
Reported: December 27, 2023 Initiated: December 11, 2023 #D-0156-2024
Product Description
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
Reason for Recall
Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
Details
- Recalling Firm
- Fagron, Inc
- Units Affected
- 9 containers
- 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.
- Location
- Saint Paul, MN
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Fagron, Inc. Units affected: 9 containers.
Why was this product recalled? ▼
Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 27, 2023. Severity: Moderate. Recall number: D-0156-2024.
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