Digoxin Tablet
FDA Recall NDC 70954-201
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Digoxin (NDC 70954-201). A significant event, classified as Class III, was initiated on Mar 25, 2024 by Ani Pharmaceuticals, Inc.. The reported reason for this action was: "Failed Impurities/Degradation Specifications"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class III Terminated
Failed Impurities/Degradation Specifications
Mar 25, 2024
Apr 24, 2024
1,003 bottles
Recall Profile & Regulatory Data
Event ID
94255
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Novitium Pharma LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S. Nationwide
Termination Date
Jul 16, 2024
Product Description
Digoxin Tablets, USP 62.5 mcg (0.0625 mg), 100-count bottles, Rx Only, Manufactured by: Novitium Pharma LLC, 70 Lake Drive, East Windsor, New Jersey 08520, NDC 70954-200-10
Batch or Lot Expiration Information
Lot# Lot M23011A; Exp. 12/2024
Affected Packages Involved in this Recall
70954-201-10Product
70954-201-20Product
70954-202-10Product
70954-202-20Product
70954-200-10Product
Class III Terminated
Cross Contamination with Other Products:(mycophenolate mofetil).
Mar 04, 2024
Mar 27, 2024
3,940 1000-count bottles
Recall Profile & Regulatory Data
Event ID
94132
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Novitium Pharma LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
Mar 21, 2025
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
Batch or Lot Expiration Information
Lot# : M23172A, Exp 01/31/2025
Affected Packages Involved in this Recall
70954-201-10Product
70954-201-20Product
70954-202-10Product
70954-202-20Product
70954-200-10Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
