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U.S. Department of Health and Human Services

Enforcement Report - Week of March 13, 2013

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Product Detail

Product Description Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate Extended-Release Capsules, 15 mg, Rx Only, C II, 100 capsules per bottle, MFG. By Actavis Elizabeth LLC. 200 Elmora Ave, Elizabeth, NJ, 07207, USA, NDC 0228-3063-11.
Recall Number D-190-2013
Classification Class III
Code Info Lot #: 50077231
Product Distributed Qty 9,264 Bottles
Reason For Recall Failed Dissolution Specification: This product recall is due to the product lot # 50077231 exceeding dissolution specifications. All other test specifications were met.

Event Detail

Event Id 64506
Product Type Drugs
Status Ongoing
Recalling Firm Actavis Elizabeth LLC
City Elizabeth
State NJ
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-02-13
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide
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