FDA recall D-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

Reason for recall

Failed Content Uniformity Specifications

Distribution

USA nationwide.

Key facts

Status

Terminated

Initiation date

2023-03-09

Report date

2023-03-29

Termination date

2023-10-18

Voluntary/Mandated

Voluntary: Firm initiated

Location

Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0474-2023