FDA 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

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2023-07-18

Report date

2023-08-16

Termination date

2024-02-26

Voluntary/Mandated

Voluntary: Firm initiated

Location

Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1082-2023