Reported Dec 27, 2023 · Ongoing
NYSTATIN 2 BU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For Prescription Compounding, Fagron,…
Fagron, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Fagron, Inc · 2400 Pilot Knob Rd · Saint Paul, MN · 55120-1118
Is this the product you have?
- NYSTATIN 2 BU
- 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 51552-0041-4, Bar code 3 51552 00414 6
- Lot codes and dates
Lot #: 230308-U46224Exp. date 04/30/2025221031-U42105Exp. date 04/30/2025
- Amount recalled
- 9 containers
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Why it was recalled
Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Fagron, Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.