FDA Drug recall D-837-2013
Reumofan Plus, 30-count tablets per bottle, distriubted by Reumofan Plus USA, LLC and Reumofan USA, LLC, Springfield, PA, and manufactured…
- FDA Drug
- Class I
- terminated
- Published 2013-08-14
On 2013-08-14 the FDA classified a Class I recall of Reumofan Plus, 30-count tablets per bottle, distriubted by Reumofan Plus USA, LLC and Reumofan USA, LLC, Springfield, PA, and manufactured… by Reumofan Plus Usa, citing marketed without an approved NDA/ANDA: Product may contain undeclared active pharmaceutical ingredients Diclofenac Sodium, Dexamethasone, and Methocarbamol.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-837-2013 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2013-01-04 |
| Published | 2013-08-14 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Reumofan Plus Usa |
| Distribution | US |
Product
Reumofan Plus, 30-count tablets per bottle, distriubted by Reumofan Plus USA, LLC and Reumofan USA, LLC, Springfield, PA, and manufactured by Riger Natural S.A., Mexico.
Reason
Marketed without an approved NDA/ANDA: Product may contain undeclared active pharmaceutical ingredients Diclofenac Sodium, Dexamethasone, and Methocarbamol.
Identifiers
| code_info | Lot #: 99515, Exp 09/2016 |
|---|
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-837-2013%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.