Fagron, Inc 2023-12-27 Health serious FDA
Health · FDA · Recall #FDA-D-0155-2024
NYSTATIN 500 MU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For… Recall
Issued December 27, 2023 · Fagron, Inc
In December 2023, Fagron, Inc recalled the NYSTATIN 500 MU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
What you should do
- 1 Stop using NYSTATIN 500 MU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Fagron, Inc to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Fagron, Inc
- Category
- Health
- Recall date
- December 27, 2023
- Units affected
- Not reported
- Sold at
- Product was distributed to 1 distributor and may have further distributed the product to repacker/relabelers and pharmacies in the United
- Recall number
- FDA-D-0155-2024
- Made in
- United States
- Issuing agency
- FDA
In context
- Fagron, Inc has 3 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 903rd Health recall we've logged in 2023.