Recalls / Class III
Class IIID-0443-2024
Product
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
- Brand name
- Digoxin
- Generic name
- Digoxin
- Active ingredient
- Digoxin
- Route
- Oral
- NDCs
- 70954-200, 70954-201, 70954-202
- FDA application
- ANDA215307
- Affected lot / code info
- Lot M23011A; Exp. 12/2024
Why it was recalled
Failed Impurities/Degradation Specifications
Recalling firm
- Firm
- Novitium Pharma LLC
- Manufacturer
- ANI Pharmaceuticals, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 70 Lake Dr, East Windsor, New Jersey 08520-5321
Distribution
- Quantity
- 1,003 bottles
- Distribution pattern
- U.S. Nationwide
Timeline
- Recall initiated
- 2024-03-25
- FDA classified
- 2024-04-13
- Posted by FDA
- 2024-04-24
- Terminated
- 2024-07-16
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0443-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.