FDA recall D-0437-2017

Product

Furosemide Tablets USP, 20 mg, 1000 count bottles, Rx only, Roxane Laboratories, Inc., Columbus, Ohio 43216, NDC 0054-4297-31.

Reason for recall

Failed Tablet/Capsule Specifications: An unusually thick tablet was reported through a complaint.

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2016-12-22

Report date

2017-02-01

Termination date

2017-12-18

Voluntary/Mandated

Voluntary: Firm initiated

Location

Columbus, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0437-2017