Class III
Terminated
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
- Recall Initiated
- July 18, 2023
- Posted
- August 16, 2023
- Recall Number
- D-1082-2023
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 360 60-count bottles
- Firm Location
- Princeton, NJ, United States
Reason for Recall
Out of Specification result observed in content uniformity testing
Distribution
Nationwide in the USA
Lot / Code Info
Lot: DNE0217A, Exp 01/2025
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