FDA Drug recall D-063-2013
Reumofan Plus Tablets, 30-count bottle per Box, (remaining label information in Spanish)
- FDA Drug
- Class I
- terminated
- Published 2012-12-05
On 2012-12-05 the FDA classified a Class I recall of Reumofan Plus Tablets, 30-count bottle per Box, (remaining label information in Spanish) by Samantha Lynn, citing 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.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-063-2013 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2012-08-27 |
| Published | 2012-12-05 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Samantha Lynn |
| Distribution | US |
Product
Reumofan Plus Tablets, 30-count bottle per Box, (remaining label information in Spanish)
Reason
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.
Identifiers
| code_info | all lots within expiry through 2016 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-063-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.