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Recall Observatory FDA recall evidence

Drug product

PIRACETAM COGNITION ENHANCING AGENT Dietary Supplement PHARMACEUTICAL GRADE 800 mg 240 Capsules per bottle CTD Labs Houston, TX 77090

D-194-2013

May 27, 2011

Class II

Product summary

Firm
A B Nutrition, Inc.
Event
Event 59001
Status
Terminated
Classification
Class II
Quantity
2980 bottles
Official record key
drug-enforcement:D-194-2013

Official wording

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

Code information: Lot #33250311 Exp. 04/13

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.