FDAFDA · Food and drugs·Recall number D-063-2013
Reumofan Plus Tablets, 30-count bottle per Box, (remaining label information in Spanish)
Published December 5, 2012 · Recall initiated: August 27, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Press Release
Recall details
- Manufacturer
- Samantha Lynn, Inc
- Distributor
- Nationwide and Canada, Australia, Germany, Brazil, Austria, United Kingdom, India, Chile, Switzerland, Thailand, Japan
- Lot
- all lots within expiry through 2016
- Risk classification
- Class I
- Area (FDA)
- drug
- Country
- United States
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