Why it was recalled
Cross Contamination with Other Products:(mycophenolate mofetil).
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 numbers, UPCs & expiration codes
Lot #: M23172A, Exp 01/31/2025
Where it was sold
Nationwide in the USA
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-0389-2024
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Mar 4, 2024
- FDA report date
- Mar 27, 2024
- Quantity
- 3,940 1000-count bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Novitium Pharma LLC
Original FDA data
Every field from FDA enforcement report D-0389-2024, exactly as published.
Show all FDA fields
- City
- East Windsor
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 94132
- Address
- 70 Lake Dr
- Code information
- Lot #: M23172A, Exp 01/31/2025
- Postal code
- 08520-5321
- Report date
- Mar 27, 2024
- Product type
- Drugs
- Recall number
- D-0389-2024
- Classification
- Class III
- Recalling firm
- Novitium Pharma LLC
- Product quantity
- 3,940 1000-count bottles
- Termination date
- Mar 21, 2025
- Reason for recall
- Cross Contamination with Other Products:(mycophenolate mofetil).
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Mar 4, 2024
- Initial firm notification
- Letter
- Center classification date
- Mar 15, 2024