Reumofan Plus Tablets, 30-count bottle per Box, (remaining label information in Spanish)
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
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 was recalled
Reumofan Plus Tablets, 30-count bottle per Box, (remaining label information in Spanish)
- Recalling firm
- Samantha Lynn, Inc
- Origin
- CA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-063-2013
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
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