Drug Enforcement D-378-2014

Marketed without an Approved NDA/ANDA: product found to contain undeclared sildenafil and tadalafil

Status

Terminated

Classification

Class I

Report Date

December 25, 2013

Termination Date

February 10, 2021

Product Information

Product description
PRO POWER MAX Natural Energy Enhancer, ALL NATURAL HERBS, supplied in 1 capsule per blister pack, Distributed by MSH Distribution LLC
Product quantity
18 blister packs of one capsule each
Reason for recall
Marketed without an Approved NDA/ANDA: product found to contain undeclared sildenafil and tadalafil
Recall initiation reason
—
Initial firm notification
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution pattern
CA, FL and UT

Location & Firm

Recalling firm
Fabscout Entertainment, Inc
Address
1458 NW 23rd Ave, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-378-2014
Event ID
66043
Recall initiation date
August 14, 2013
Center classification date
December 18, 2013
Code info
All Lots
More code info
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