D-1091-2014 Class II Terminated

Recalled by Actavis Elizabeth LLC — Elizabeth, NJ

Recall Details

Product Type
Drugs
Report Date
March 12, 2014
Initiation Date
February 4, 2014
Termination Date
January 22, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
5,148 bottles

Product Description

Alprazolam Extended-Release Tablets, USP, 3 mg, 60-count tablets per bottle, Rx only, Manufactured by: Actavis Elizabeth LLC, 200 Elmora Avenue, Elizabeth, NJ 07207, NDC 0228-3086-06, UPC 3 0228-3086-06 2.

Reason for Recall

Failed Dissolution Specifications: Product did not meet specification requirements for dissolution.

Distribution Pattern

Nationwide

Code Information

Lot #: 57617531, Exp 03/14