FDA Recall D-1346-2014
Tendex · Beverly Hills, CA
Class I — life-threatening Terminated 303 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
NATURECT Capsules Dietary Supplement 500 mg, supplied in 1 count blister pack and 5, 10, 20, and 40- count bottles, Distributed by P-Boost, Los Angeles, CA 900466
Reason for recall
Marketed Without an Approved NDA/ANDA: FDA analysis found the product to contain undeclared active ingredient, tadalafil, thus making these products unapproved drugs.
Recall record
- Recall number
D-1346-2014- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- Nationwide.
- Recall initiated
- 2013-11-19
- Classified by FDA Center
- 2014-05-21
- FDA published
- 2014-05-28
- Terminated
- 2014-09-18
- Recalling firm
- Tendex
- Firm location
- Beverly Hills, CA