FDA Recall D-0154-2024
Fagron, Inc · Saint Paul, MN
Class II Ongoing 885 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
Product
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
Reason for recall
Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
Recall record
- Recall number
D-0154-2024- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- 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.
- Recall initiated
- 2023-12-11
- Classified by FDA Center
- 2023-12-21
- FDA published
- 2023-12-27
- Recalling firm
- Fagron, Inc
- Firm location
- Saint Paul, MN
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.