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U.S. Department of Health and Human Services

Enforcement Report - Week of March 5, 2014

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Product Detail

Product Description Clonazepam Tablets, USP 2 mg 100 tablets Manufactured by: Actavis Elizabeth LLC 200 Elmora Avenue, Elizabeth, NJ 0737 USA NDC 0228-3005-11 packaged in White/Round HDPE 75 CC with white/round plastic 33 mm CRC closure shipped in corrugated 75 cc carton (24 bottles/carton)
Recall Number D-1087-2014
Classification Class II
Code Info lot 58468552 Exp. 05/15
Product Distributed Qty 13,608 bottles
Reason For Recall Subpotent Drug: During routine stability testing one tablet was found with tablet weight below specification.

Event Detail

Event Id 67053
Product Type Drugs
Status Ongoing
Recalling Firm Actavis Elizabeth LLC
City Elizabeth
State NJ
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-11-06
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide