Drug Enforcement D-233-2013

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
Piracetam & Choline, 390mg Piracetam 104mg Choline Capsules, a) 30 count bottle, b) 100 count bottle, OTC, BoostYourGrade, LLC, Orlando, FL. 32826 ,
Product quantity
511 30 count bottles, 4103 100 count 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-233-2013
Event ID
64619
Recall initiation date
March 11, 2013
Center classification date
April 1, 2013
Code info
All lot codes.
More code info