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Recall Observatory FDA recall evidence

Drug product

ANIRACETAM FAST ACTING NOOTROPIC Dietary Supplement PHARMACEUTICAL GRADE 750mg 60 Capsules per bottle CTD Labs Houston, TX 77090

D-196-2013

May 27, 2011

Class II

Product summary

Firm
A B Nutrition, Inc.
Event
Event 59001
Status
Terminated
Classification
Class II
Quantity
912 bottles
Official record key
drug-enforcement:D-196-2013

Official wording

Reason: Marketed Without an Approved NDA/ANDA: The product is an unapproved new drug.

Code information: Lot # 32000311

Distribution pattern: In retail store located in TX and internet sales nationwide.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Marketed Without an Approved NDA/ANDA: The product is an unapproved new drug.