Digoxin Tablets, USP 125mcg, (0.125 mg), 1000-count bottle, Rx Only, Manufactured by: Novitium Pharma LLC., 70 Lake Driv
Summary
The FDA issued a Class III for Digoxin Tablets, USP 125mcg, (0.125 mg), 1000-count bottle, Rx Only, Manufacture by Novitium Pharma LLC. Reason: Cross Contamination with Other Products:(mycophenolate mofetil)..
Details
Source
Drug Recall
External ID
D-0389-2024
Action Date
2024-03-27
Status
Terminated
Category
drug
Product Description
Digoxin Tablets, USP 125mcg, (0.125 mg), 1000-count bottle, Rx Only, Manufactured by: Novitium Pharma LLC., 70 Lake Drive, East Windsor, New Jersey 08520, NDC 70954-201-20
Lot/Code Info: Lot #: M23172A, Exp 01/31/2025
Quantity Affected: 3,940 1000-count bottles
Reason for Recall
Cross Contamination with Other Products:(mycophenolate mofetil).
Distribution
Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2024-03-04
Company
East Windsor, NJ
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 47 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Novitium Pharma LLC has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
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 (Novitium Pharma LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Novitium Pharma LLC have FDA actions?
Novitium Pharma LLC has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0389-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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