FDA Drug Recalls

Recalls / Class II

Class IID-230-2013

Product

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

Affected lot / code info
All lot codes.

Why it was recalled

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

Recalling firm

Firm
Palmer Natural Products
Notification channel
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Type
Voluntary: Firm initiated
Address
11665 W State St, N/A, Star, Idaho 83669-5223

Distribution

Quantity
557 30 count botles, 672 60 count bottles, 1,102 90 count bottles, 250 180 count bottles
Distribution pattern
Florida, Idaho, California and Hong Kong. This product can be ordered on line.

Timeline

Recall initiated
2013-03-11
FDA classified
2013-04-01
Posted by FDA
2013-04-10
Terminated
2013-08-07
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-230-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.

Class II recall: drug · FDA Drug Recalls