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U.S. Department of Health and Human Services

Enforcement Report - Week of March 19, 2014

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Product Detail

Product Description Alprazolam 1 mg Tablets, USP, 500 count Bottle, Rx Only , C IV, Manufactured by: Actavis Elizabeth LLC 200 Elmora Avenue Elizabeth, NJ 07207 USA, NDC 0228-2031-50
Recall Number D-1153-2014
Classification Class II
Code Info Lot # 1826E131, Exp 04/2015
Product Distributed Qty 9447 Bottles
Reason For Recall Failed Tablet/Capsule Specifications: Complaints were received for significant tablet erosion for Alprazolam 1 mg.

Event Detail

Event Id 67519
Product Type Drugs
Status Ongoing
Recalling Firm Actavis Elizabeth LLC
City Elizabeth
State NJ
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-02-10
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide