PIRACETAM COGNITION ENHANCING AGENT Dietary Supplement PHARMACEUTICAL GRADE 800 mg 240 Capsules p...

FDA Recall #D-194-2013 — Class II — May 27, 2011

Recall #D-194-2013 Date: May 27, 2011 Classification: Class II Status: Terminated

Product Description

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

Reason for Recall

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

Recalling Firm

A B Nutrition, Inc. — Spring, TX

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

2980 bottles

Distribution

In retail store located in TX and internet sales nationwide.

Code Information

Lot #33250311 Exp. 04/13

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated