Recalls / Class II
Class IID-0157-2024
Product
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
- Affected lot / code info
- Lot #: 221031-U42104, Exp. date 04/30/2025
Why it was recalled
Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
Recalling firm
- Firm
- Fagron, Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2400 Pilot Knob Rd, N/A, Saint Paul, Minnesota 55120-1118
Distribution
- Quantity
- 52 containers
- 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.
Timeline
- Recall initiated
- 2023-12-11
- FDA classified
- 2023-12-21
- Posted by FDA
- 2023-12-27
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0157-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.