D-230-2013 Class II Terminated

Recalled by Palmer Natural Products — Star, ID

FDA drug recall D-230-2013 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: 557 30 count botles, 672 60 count bottles, 1,102 90 count bottles, 250 180 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
557 30 count botles, 672 60 count bottles, 1,102 90 count bottles, 250 180 count bottles

Product Description

Aniracetam & Choline capsules, 430mg Aniracetam 88mg Choline, a) 30 count bottle b) 60 count bottle, c) 90 count, d) 180 count , 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.