Recalls / Class III
Class IIID-1082-2023
Product
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
- Brand name
- Dofetilide
- Generic name
- Dofetilide
- Active ingredient
- Dofetilide
- Route
- Oral
- NDCs
- 47335-061, 47335-062, 47335-063
- FDA application
- ANDA210466
- Affected lot / code info
- Lot: DNE0217A, Exp 01/2025
Why it was recalled
Out of Specification result observed in content uniformity testing
Recalling firm
- Firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2 Independence Way, N/A, Princeton, New Jersey 08540-6620
Distribution
- Quantity
- 360 60-count bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2023-07-18
- FDA classified
- 2023-08-07
- Posted by FDA
- 2023-08-16
- Terminated
- 2024-02-26
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1082-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.