Drug product
Reumofan Plus Tablets, 30-count bottle per Box, (remaining label information in Spanish)
D-063-2013
Product summary
- Event
- Event 63017
- Status
- Terminated
- Classification
- Class I
- Quantity
- 25,888 Boxes
- Official record key
drug-enforcement:D-063-2013
Official wording
Reason: 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.
Code information: all lots within expiry through 2016
Distribution pattern: Nationwide and Canada, Australia, Germany, Brazil, Austria, United Kingdom, India, Chile, Switzerland, Thailand, Japan
Derived failure modes
-
Unknown
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.