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Recall Observatory FDA recall evidence

Drug product

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

D-236-2013

March 11, 2013

Class II

Product summary

Firm
Palmer Natural Products
Event
Event 64619
Status
Terminated
Classification
Class II
Quantity
472 - 30 count bottles; 203 - 60 count bottles; 458 - 90 count bottles
Official record key
drug-enforcement:D-236-2013

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