Status
Terminated
Drug Enforcement D-236-2013
Marketed Without an Approved NDA/ANDA: The products are unapproved drugs
Classification
Class II
Report Date
April 10, 2013
Termination Date
August 7, 2013
Product Information
- Product description
- Oxiracetam & Choline , Oxiracetam 460mg Choline 110mg capsules a) 30 count bottle, b) 60 count bottle, c) 90 count bottle, OTC, BoostYourGrade, LLC, Orlando, FL. 32826
- Product quantity
- 472 - 30 count bottles; 203 - 60 count bottles; 458 - 90 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-236-2013
- Event ID
- 64619
- Recall initiation date
- March 11, 2013
- Center classification date
- April 1, 2013
- Code info
- All lot codes
- More code info
- —