Recalls / Class III
Class IIID-0474-2023
Product
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
- Affected lot / code info
- Lot # DND1541A, Exp 08/2024
Why it was recalled
Failed Content Uniformity Specifications
Recalling firm
- Firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2 Independence Way, N/A, Princeton, New Jersey 08540-6620
Distribution
- Quantity
- 1,920 bottles
- Distribution pattern
- USA nationwide.
Timeline
- Recall initiated
- 2023-03-09
- FDA classified
- 2023-03-22
- Posted by FDA
- 2023-03-29
- Terminated
- 2023-10-18
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0474-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.