Nystatin 150 MU recall: Labeling Error
NYSTATIN 150 MU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For Prescription Compounding, Fagron, Inc. - 2400 Pilot Knob Rd. St…
Why was Nystatin 150 MU recalled?
Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: 221031-U42104, Exp. date 04/30/2025
- 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…
- Recalling firm
- Fagron, Inc
- Quantity
- 52 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.
- Recall date
- December 27, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)