FDA Recall D-0020-2017
Bee Xtreme · Punxsutawney, PA
Class I — life-threatening Terminated 404 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
Oasis Dietary Supplement Capsules, 500 mg, 45 count bottles, Manufactured for Timeless Solutions, 1810 E Sahara Ave #100, Las Vegas, Nevada 89104, distributed by BeeXtreme LLC, Punxsutawney PA
Reason for recall
Marketed without an Approved NDA/ANDA; FDA analysis found them to contain sibutramine and phenolphthalein
Recall record
- Recall number
D-0020-2017- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Distribution
- Unknown
- Recall initiated
- 2015-12-23
- Classified by FDA Center
- 2016-10-12
- FDA published
- 2016-10-19
- Terminated
- 2017-01-30
- Recalling firm
- Bee Xtreme
- Firm location
- Punxsutawney, PA