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U.S. Department of Health and Human Services

Enforcement Report - Week of March 12, 2014

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Product Detail

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.
Recall Number D-1091-2014
Classification Class II
Code Info Lot #: 57617531, Exp 03/14
Product Distributed Qty 5,148 bottles
Reason For Recall Failed Dissolution Specifications: Product did not meet specification requirements for dissolution.

Event Detail

Event Id 67518
Product Type Drugs
Status Ongoing
Recalling Firm Actavis Elizabeth LLC
City Elizabeth
State NJ
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-02-04
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide
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