FDA Recall D-378-2014
Fabscout Entertainment, Inc · Ft Lauderdale, FL
Class I — life-threatening Terminated 2737 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
PRO POWER MAX Natural Energy Enhancer, ALL NATURAL HERBS, supplied in 1 capsule per blister pack, Distributed by MSH Distribution LLC
Reason for recall
Marketed without an Approved NDA/ANDA: product found to contain undeclared sildenafil and tadalafil
Recall record
- Recall number
D-378-2014- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Distribution
- CA, FL and UT
- Recall initiated
- 2013-08-14
- Classified by FDA Center
- 2013-12-18
- FDA published
- 2013-12-25
- Terminated
- 2021-02-10
- Recalling firm
- Fabscout Entertainment, Inc
- Firm location
- Ft Lauderdale, FL