Drug recall D-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
Reason for recall
Out of Specification result observed in content uniformity testing
Lots and codes
Lot: DNE0217A, Exp 01/2025
Recall details
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC, Princeton, NJ
- Quantity
- 360 60-count bottles
- Distribution
- Nationwide in the USA
- Type
- Voluntary: Firm initiated
- Recall initiated
- July 18, 2023
- Terminated
- February 26, 2024
Related products
- Dofetilide – drug information
- NDC 47335-063 Dofetilide · Dofetilide .5 mg/1 · Sun Pharmaceutical Industries, Inc.
- NDC 47335-061 Dofetilide · Dofetilide .125 mg/1 · Sun Pharmaceutical Industries, Inc.
- NDC 47335-062 Dofetilide · Dofetilide .25 mg/1 · Sun Pharmaceutical Industries, Inc.