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Class III: unlikely to cause harmTerminated

Novitium Pharma Digoxin Tablets Recall

Digoxin Tablets, USP 62

Novitium Pharma LLC · East Windsor, NJ

Risk level
Class III
Reported by FDA
Apr 24, 2024
Recall ID
D-0443-2024
Check your lot numberHow we source this data

Summary

Novitium Pharma recalled Digoxin Tablets starting Mar 25, 2024. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-0443-2024 on Apr 24, 2024. Reason: Failed Impurities/Degradation Specifications. Status: Terminated.

Why it was recalled

Failed Impurities/Degradation Specifications

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

Lot numbers, UPCs & expiration codes

Lot M23011A; Exp. 12/2024

Where it was sold

U.S. Nationwide

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0443-2024
Classification
Class III
Status
Terminated
Recall initiated
Mar 25, 2024
FDA report date
Apr 24, 2024
Quantity
1,003 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Novitium Pharma LLC

Original FDA data

Every field from FDA enforcement report D-0443-2024, exactly as published.

Show all FDA fields
City
East Windsor
State
NJ
Status
Terminated
Country
United States
Event ID
94255
Address
70 Lake Dr
Code information
Lot M23011A; Exp. 12/2024
Postal code
08520-5321
Report date
Apr 24, 2024
Product type
Drugs
Recall number
D-0443-2024
Classification
Class III
Recalling firm
Novitium Pharma LLC
Product quantity
1,003 bottles
Termination date
Jul 16, 2024
Reason for recall
Failed Impurities/Degradation Specifications
Voluntary / mandated
Voluntary: Firm initiated
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
Distribution pattern
U.S. Nationwide
Recall initiation date
Mar 25, 2024
Initial firm notification
Letter
Center classification date
Apr 13, 2024

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0443-2024, published Apr 24, 2024. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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