FDA recall D-063-2013

Product

Reumofan Plus Tablets, 30-count bottle per Box, (remaining label information in Spanish)

Reason for recall

Marketed without an approved NDA/ANDA: Samantha Lynn Inc. is recalling Reumofan Plus Tablets because it contains undeclared drug ingredients making it an unapproved drug.

Distribution

Nationwide and Canada, Australia, Germany, Brazil, Austria, United Kingdom, India, Chile, Switzerland, Thailand, Japan

Key facts

Status

Terminated

Initiation date

2012-08-27

Report date

2012-12-05

Termination date

2013-03-18

Voluntary/Mandated

Voluntary: Firm initiated

Location

Norwalk, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-063-2013