Drug Enforcement D-234-2013

Marketed Without an Approved NDA/ANDA: The products are unapproved drugs

Status

Terminated

Classification

Class II

Report Date

April 10, 2013

Termination Date

August 7, 2013

Product Information

Product description
Brain Defogger, Piracetam 390mg Choline 104mg capsules, 100 count bottle, OTC, BoostYourGrade, LLC, Orlando, FL. .
Product quantity
4103 bottles
Reason for recall
Marketed Without an Approved NDA/ANDA: The products are unapproved drugs
Recall initiation reason
Initial firm notification
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution pattern
Florida, Idaho, California and Hong Kong. This product can be ordered on line.

Location & Firm

Recalling firm
Palmer Natural Products
Address
11665 W State St, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date

Codes & Dates

Recall number
D-234-2013
Event ID
64619
Recall initiation date
March 11, 2013
Center classification date
April 1, 2013
Code info
All lot codes.
More code info