Home / Recalls / A B Nutrition, Inc. / D-194-2013

D-194-2013 Class II Terminated

Recalled by A B Nutrition, Inc. — Spring, TX

FDA drug recall D-194-2013 was initiated by A B Nutrition, Inc. on May 27, 2011 and is designated Class II. Reason for recall: Marketed Without an Approved NDA/ANDA: The product is an unapproved new drug. The recall status is terminated (terminated July 29, 2013). Affected quantity: 2980 bottles.

Recall Details

Product Type: Drugs
Report Date: March 20, 2013
Initiation Date: May 27, 2011
Termination Date: July 29, 2013
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 2980 bottles

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.

Distribution Pattern

In retail store located in TX and internet sales nationwide.

Code Information

Lot #33250311 Exp. 04/13