Recalls / Class I
Class ID-378-2014
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
Product
PRO POWER MAX Natural Energy Enhancer, ALL NATURAL HERBS, supplied in 1 capsule per blister pack, Distributed by MSH Distribution LLC
- Affected lot / code info
- All Lots
Why it was recalled
Marketed without an Approved NDA/ANDA: product found to contain undeclared sildenafil and tadalafil
Recalling firm
- Firm
- Fabscout Entertainment, Inc
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 1458 NW 23rd Ave, N/A, Ft Lauderdale, Florida 33311-5147
Distribution
- Quantity
- 18 blister packs of one capsule each
- Distribution pattern
- CA, FL and UT
Timeline
- Recall initiated
- 2013-08-14
- FDA classified
- 2013-12-18
- Posted by FDA
- 2013-12-25
- Terminated
- 2021-02-10
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-378-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.