Reumofan Plus Tablets — Class I drug recall D-063-2013
Terminated recall by Samantha Lynn, Inc, reported 2012-12-05, distributed nationwide. Marketed without an approved NDA/ANDA: Samantha Lynn Inc. is recalling Reumofan Plus Tablets because it contai
| Recall number | D-063-2013 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Samantha Lynn, Inc, Norwalk, CA, United States |
| Recall initiated | 2012-08-27 |
| Classified | 2012-11-23 |
| Reported by FDA | 2012-12-05 |
| Terminated | 2013-03-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BR, CA, CH, CL, DE, GB, IN, JP, TH |
| Quantity | 25,888 boxes |
| Reason classes | undeclared allergen, unapproved product |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-063-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.