FDA Recall D-837-2013
Reumofan Plus USA · Springfield, PA
Class I — life-threatening Terminated 755 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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.
Recall record
- Recall number
D-837-2013- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide through internet sales.
- Recall initiated
- 2013-01-04
- Classified by FDA Center
- 2013-08-02
- FDA published
- 2013-08-14
- Terminated
- 2015-01-29
- Recalling firm
- Reumofan Plus USA
- Firm location
- Springfield, PA