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.
Recall initiated: 20120827
Status: Terminated
Classification: Class I
Recall type: Voluntary: Firm initiated