US Drug Recall Register
Class I · High risk Terminated Initiated Aug 27, 2012 (14 years ago)

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.