D-196-2013 Class II Terminated

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

FDA drug recall D-196-2013 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: 912 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
912 bottles

Product Description

ANIRACETAM FAST ACTING NOOTROPIC Dietary Supplement PHARMACEUTICAL GRADE 750mg 60 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 # 32000311