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U.S. Department of Health and Human Services

Enforcement Report - Week of March 13, 2013

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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
Distribution Pattern Nationwide

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. Lot #: 50077231 Class III Failed Dissolution Specification: This product recall is due to the product lot # 50077231 exceeding dissolution specifications. All other test specifications were met. 9,264 Bottles D-190-2013