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U.S. Department of Health and Human Services

Enforcement Report - Week of March 6, 2013

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Product Detail

Product Description Dextroamphetamine Sulfate Extended Release Capsules, 5 mg, 90 capsules, Rx only, Manufactured by Catalent Pharma Solutions for CorePharma, LLC Middlesex, NJ 08846 NDC 64720-328-09
Recall Number D-172-2013
Classification Class II
Code Info Lot 220839, exp 11/30/2013
Product Distributed Qty 12,948 bottles
Reason For Recall Failed Dissolution Specifications: The affected lots may not meet the specifications for dissolution over the product shelf life.

Event Detail

Event Id 63926
Product Type Drugs
Status Ongoing
Recalling Firm Amedra Pharmaceuticals LLC
City Horsham
State PA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-12-04
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide and Puerto Rico.