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

Recall Number: D-063-2013

Firm: Samantha Lynn, Inc

Classification: Class I

Status: Terminated

Report Date: 20121205

Initiation Date: 20120827

Termination Date: 20130318

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.

Product Description

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