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Recall Observatory FDA recall evidence

Drug product

Aniracetam and Choline, Aniracetam 460 mg, Choline 76 mg, 180 capsules per bottler, non-Rx, distributed by BoostYourGrade, BoostYourGrade, LLC Orlando, FL

D-232-2013

March 11, 2013

Class II

Product summary

Firm
Palmer Natural Products
Event
Event 64619
Status
Terminated
Classification
Class II
Quantity
250 bottles
Official record key
drug-enforcement:D-232-2013

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