FDA Recall D-0906-2016
R Thomas Marketing, LLC · Bronx, NY
Class I — life-threatening Terminated 1259 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
Super Hard, packaged in BIG BOX (20 small boxes / 6 capsules per box / 120 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
Reason for recall
Marketed Without An Approved NDA/ANDA
Recall record
- Recall number
D-0906-2016- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- Nationwide via Internet sales
- Recall initiated
- 2016-01-09
- Classified by FDA Center
- 2016-05-26
- FDA published
- 2016-06-01
- Terminated
- 2019-06-21
- Recalling firm
- R Thomas Marketing, LLC
- Firm location
- Bronx, NY