D-233-2013 Class II Terminated
FDA drug recall D-233-2013 was initiated by Palmer Natural Products on March 11, 2013 and is designated Class II. Reason for recall: Marketed Without an Approved NDA/ANDA: The products are unapproved drugs The recall status is terminated (terminated August 7, 2013). Affected quantity: 511 30 count bottles, 4103 100 count bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- April 10, 2013
- Initiation Date
- March 11, 2013
- Termination Date
- August 7, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 511 30 count bottles, 4103 100 count bottles
Product Description
Piracetam & Choline, 390mg Piracetam 104mg Choline Capsules, a) 30 count bottle, b) 100 count bottle, OTC, BoostYourGrade, LLC, Orlando, FL. 32826 ,
Reason for Recall
Marketed Without an Approved NDA/ANDA: The products are unapproved drugs
Distribution Pattern
Florida, Idaho, California and Hong Kong. This product can be ordered on line.
Code Information
All lot codes.