Why it was recalled
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
Lot numbers, UPCs & expiration codes
Lot #: 221031-U42104, Exp. date 04/30/2025
Where it was sold
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.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0157-2024
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Dec 11, 2023
- FDA report date
- Dec 27, 2023
- Quantity
- 52 containers
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Fagron, Inc
Original FDA data
Every field from FDA enforcement report D-0157-2024, exactly as published.
Show all FDA fields
- City
- Saint Paul
- State
- MN
- Status
- Ongoing
- Country
- United States
- Event ID
- 93594
- Address
- 2400 Pilot Knob Rd
- Code information
- Lot #: 221031-U42104, Exp. date 04/30/2025
- Postal code
- 55120-1118
- Report date
- Dec 27, 2023
- Product type
- Drugs
- Recall number
- D-0157-2024
- Classification
- Class II
- Recalling firm
- Fagron, Inc
- Product quantity
- 52 containers
- Reason for recall
- Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Recall initiation date
- Dec 11, 2023
- Initial firm notification
- Letter
- Center classification date
- Dec 21, 2023