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U.S. Department of Health and Human Services

Enforcement Report - Week of August 14, 2013

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Product Detail

Product Description Methylphenidate Hydrochloride Extended-Release Capsules (LA), 40 mg, 100 count bottle, Rx only, TEVA PHARMACEUTICALS USA, NDC 0093-5348-01
Recall Number D-849-2013
Classification Class II
Code Info 34010287A, 34010288A, 34010289A, exp 4/2014; 34011513A, 34011514A, and 34011515A, exp 06/14.
Product Distributed Qty 7,579 bottles
Reason For Recall Failed Dissolution Specifications: Product is being recalled due to out of specification dissolution results obtained during routine stability testing.

Event Detail

Event Id 65515
Product Type Drugs
Status Ongoing
Recalling Firm Teva Pharmaceuticals USA, Inc.
City Sellersville
State PA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-06-18
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide