Why it was recalled
Out of Specification result observed in content uniformity testing
Product description
Dofetilide Capsules 500 mcg (0.5mg), 60-count bottle, Rx Only, Manufactured by Sun Pharmaceutical Industries Limited, Survey No. 259/15, Dadra-396 191, (U.T of D & NH), India, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512. NDC 47335-063-86
Lot numbers, UPCs & expiration codes
Lot: DNE0217A, Exp 01/2025
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-1082-2023
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jul 18, 2023
- FDA report date
- Aug 16, 2023
- Quantity
- 360 60-count bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
Original FDA data
Every field from FDA enforcement report D-1082-2023, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 92725
- Address
- 2 Independence Way
- Code information
- Lot: DNE0217A, Exp 01/2025
- Postal code
- 08540-6620
- Report date
- Aug 16, 2023
- Product type
- Drugs
- Recall number
- D-1082-2023
- Classification
- Class III
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Product quantity
- 360 60-count bottles
- Termination date
- Feb 26, 2024
- Reason for recall
- Out of Specification result observed in content uniformity testing
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Dofetilide Capsules 500 mcg (0.5mg), 60-count bottle, Rx Only, Manufactured by Sun Pharmaceutical Industries Limited, Survey No. 259/15, Dadra-396 191, (U.T of D & NH), India, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512. NDC 47335-063-86
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Jul 18, 2023
- Initial firm notification
- Letter
- Center classification date
- Aug 7, 2023