Enforcement Report - Week of December 5, 2012
-
Back to Previous Page
Product Detail
| Product Description | Reumofan Plus Tablets, 30-count bottle per Box, (remaining label information in Spanish) |
|---|---|
| Recall Number | D-063-2013 |
| Classification | Class I |
| Code Info | all lots within expiry through 2016 |
| Product Distributed Qty | 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. |
Event Detail
| Event Id | 63017 |
|---|---|
| Product Type | Drugs |
| Status | Ongoing |
| Recalling Firm | Samantha Lynn, Inc |
| City | Norwalk |
| State | CA | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-08-27 |
| Initial Firm Notification of Consignee or Public | Press Release |
| Distribution Pattern | Nationwide and Canada, Australia, Germany, Brazil, Austria, United Kingdom, India, Chile, Switzerland, Thailand, Japan |
-
