D-837-2013 Class I Terminated
FDA drug recall D-837-2013 was initiated by Reumofan Plus USA on January 4, 2013 and is designated Class I. Reason for recall: Marketed without an approved NDA/ANDA: Product may contain undeclared active pharmaceutical ingredients Diclofenac Sodium, Dexamethasone, and Methocarbamol. The recall status is terminated (terminated January 29, 2015). Affected quantity: 586 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- August 14, 2013
- Initiation Date
- January 4, 2013
- Termination Date
- January 29, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 586 bottles
Product Description
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 Pattern
Nationwide through internet sales.
Code Information
Lot #: 99515, Exp 09/2016