FDA recall D-837-2013

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 for recall

Marketed without an approved NDA/ANDA: Product may contain undeclared active pharmaceutical ingredients Diclofenac Sodium, Dexamethasone, and Methocarbamol.

Distribution

Nationwide through internet sales.

Key facts

Status

Terminated

Initiation date

2013-01-04

Report date

2013-08-14

Termination date

2015-01-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Springfield, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-837-2013