NYSTATIN 150 MU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For Prescription Compounding, Fagron,
Summary
The FDA issued a Class II for NYSTATIN 150 MU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only by Fagron, Inc. Reason: Labeling: Label Error on Declared Strength: Assay value on the label is incorrect..
Details
Source
Drug Recall
External ID
D-0157-2024
Action Date
2023-12-27
Status
Ongoing
Category
drug
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/Code Info: Lot #: 221031-U42104, Exp. date 04/30/2025
Quantity Affected: 52 containers
Reason for Recall
Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-12-11
Company
Saint Paul, MN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 25 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Fagron, Inc has 10 FDA actions in our database, including 10 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Fagron, Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Fagron, Inc have FDA actions?
Fagron, Inc has 10 FDA actions in our database, including 10 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0157-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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