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Recall Observatory FDA recall evidence

Drug product

Piracetam & Choline, 390mg Piracetam 104mg Choline Capsules, a) 30 count bottle, b) 100 count bottle, OTC, BoostYourGrade, LLC, Orlando, FL. 32826 ,

D-233-2013

March 11, 2013

Class II

Product summary

Firm
Palmer Natural Products
Event
Event 64619
Status
Terminated
Classification
Class II
Quantity
511 30 count bottles, 4103 100 count bottles
Official record key
drug-enforcement:D-233-2013

Official wording

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

Code information: All lot codes.

Distribution pattern: Florida, Idaho, California and Hong Kong. This product can be ordered on line.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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