Status
Terminated
Drug Enforcement D-837-2013
Marketed without an approved NDA/ANDA: Product may contain undeclared active pharmaceutical ingredients Diclofenac Sodium, Dexamethasone, and Methocarbamol.
Classification
Class I
Report Date
August 14, 2013
Termination Date
January 29, 2015
Product Information
- 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.
- Product quantity
- 586 bottles
- Reason for recall
- Marketed without an approved NDA/ANDA: Product may contain undeclared active pharmaceutical ingredients Diclofenac Sodium, Dexamethasone, and Methocarbamol.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide through internet sales.
Location & Firm
- Recalling firm
- Reumofan Plus USA
- Address
-
737 Buttonwood Dr., N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-837-2013
- Event ID
- 64182
- Recall initiation date
- January 4, 2013
- Center classification date
- August 2, 2013
- Code info
- Lot #: 99515, Exp 09/2016
- More code info
- —