D-063-2013 Class I Terminated
FDA drug recall D-063-2013 was initiated by Samantha Lynn, Inc on August 27, 2012 and is designated Class I. 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. The recall status is terminated (terminated March 18, 2013). Affected quantity: 25,888 Boxes.
Recall Details
- Product Type
- Drugs
- Report Date
- December 5, 2012
- Initiation Date
- August 27, 2012
- Termination Date
- March 18, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 25,888 Boxes
Product Description
Reumofan Plus Tablets, 30-count bottle per Box, (remaining label information in Spanish)
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 Pattern
Nationwide and Canada, Australia, Germany, Brazil, Austria, United Kingdom, India, Chile, Switzerland, Thailand, Japan
Code Information
all lots within expiry through 2016