Status
Terminated
Drug Enforcement D-063-2013
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.
Classification
Class I
Report Date
December 5, 2012
Termination Date
March 18, 2013
Product Information
- Product description
- Reumofan Plus Tablets, 30-count bottle per Box, (remaining label information in Spanish)
- Product quantity
- 25,888 Boxes
- 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.
- Recall initiation reason
- —
- Initial firm notification
- Press Release
- Distribution pattern
- Nationwide and Canada, Australia, Germany, Brazil, Austria, United Kingdom, India, Chile, Switzerland, Thailand, Japan
Location & Firm
- Recalling firm
- Samantha Lynn, Inc
- Address
-
10503 Meadow Rd, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-063-2013
- Event ID
- 63017
- Recall initiation date
- August 27, 2012
- Center classification date
- November 23, 2012
- Code info
- all lots within expiry through 2016
- More code info
- —