Why it was recalled
Failed Content Uniformity Specifications
Product description
Dofetilide Capsules, 500 mcg (0.5 mg), 60-count bottle, Rx only, Manufactured by: Sun Pharmaceutical Industries Limited, Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), India, NDC 47335-0063-86
Lot numbers, UPCs & expiration codes
Lot # DND1541A, Exp 08/2024
Where it was sold
USA 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-0474-2023
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Mar 9, 2023
- FDA report date
- Mar 29, 2023
- Quantity
- 1,920 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
Original FDA data
Every field from FDA enforcement report D-0474-2023, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 91871
- Address
- 2 Independence Way
- Code information
- Lot # DND1541A, Exp 08/2024
- Postal code
- 08540-6620
- Report date
- Mar 29, 2023
- Product type
- Drugs
- Recall number
- D-0474-2023
- Classification
- Class III
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Product quantity
- 1,920 bottles
- Termination date
- Oct 18, 2023
- Reason for recall
- Failed Content Uniformity Specifications
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Dofetilide Capsules, 500 mcg (0.5 mg), 60-count bottle, Rx only, Manufactured by: Sun Pharmaceutical Industries Limited, Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), India, NDC 47335-0063-86
- Distribution pattern
- USA nationwide.
- Recall initiation date
- Mar 9, 2023
- Initial firm notification
- Letter
- Center classification date
- Mar 22, 2023