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U.S. Department of Health and Human Services

Enforcement Report - Week of January 1, 2014

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Product Detail

Product Description Dexedrine® (Dextroamphetamine Sulfate) Spansules® Sustained Release Capsules 15mg, 90 count bottle, Rx only, Manufactured by Catalent Pharma Solutions Winchester, KY 40391 for Amedra Pharmaceuticals, LLC Middlesex, NJ 08846, NDC 52054-514-09
Recall Number D-385-2014
Classification Class II
Code Info Lot# 243459; Exp. 01/14
Product Distributed Qty 10,992 bottles
Reason For Recall Failed Dissolution Specifications: Out of Specification (OOS) test results for Hour-4 at the 32 month CRT Stability Level.

Event Detail

Event Id 66593
Product Type Drugs
Status Ongoing
Recalling Firm Amedra Pharmaceuticals LLC
City Horsham
State PA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-10-07
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide