FDA Recall D-063-2013
Samantha Lynn, Inc · Norwalk, CA
Class I — life-threatening Terminated 203 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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 record
- Recall number
D-063-2013- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- Nationwide and Canada, Australia, Germany, Brazil, Austria, United Kingdom, India, Chile, Switzerland, Thailand, Japan
- Recall initiated
- 2012-08-27
- Classified by FDA Center
- 2012-11-23
- FDA published
- 2012-12-05
- Terminated
- 2013-03-18
- Recalling firm
- Samantha Lynn, Inc
- Firm location
- Norwalk, CA