FDA-Drug2012-12-05Class I
Reumofan Plus Tablets, 30-count bottle per Box, (remaining label information in Spanish)
Samantha Lynn, Inc
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.
Sold states
Nationwide and Canada, Australia, Germany, Brazil, Austria, United Kingdom, India, Chile, Switzerland, Thailand, Japan
Affected count
25,888 Boxes
Manufactured in
10503 Meadow Rd, N/A, Norwalk, CA, United States
Products
Reumofan Plus Tablets, 30-count bottle per Box, (remaining label information in Spanish)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-063-2013Don't want to check this manually?
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