Class I
Terminated
Reumofan Plus Tablets, 30-count bottle per Box, (remaining label information in Spanish)
- Company
- Samantha Lynn, Inc
- Recall Initiated
- August 27, 2012
- Posted
- December 5, 2012
- Recall Number
- D-063-2013
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 25,888 Boxes
- Firm Location
- Norwalk, CA, United States
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.
Distribution
Nationwide and Canada, Australia, Germany, Brazil, Austria, United Kingdom, India, Chile, Switzerland, Thailand, Japan
Lot / Code Info
all lots within expiry through 2016
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