Recalls / Class III
Class IIID-0389-2024
Product
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
- 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 #: M23172A, Exp 01/31/2025
Why it was recalled
Cross Contamination with Other Products:(mycophenolate mofetil).
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
- 3,940 1000-count bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2024-03-04
- FDA classified
- 2024-03-15
- Posted by FDA
- 2024-03-27
- Terminated
- 2025-03-21
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0389-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.