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U.S. Department of Health and Human Services

Enforcement Report - Week of August 14, 2013

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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

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Methylphenidate Hydrochloride Extended-Release Capsules (LA), 40 mg, 100 count bottle, Rx only, TEVA PHARMACEUTICALS USA, NDC 0093-5348-01 34010287A, 34010288A, 34010289A, exp 4/2014; 34011513A, 34011514A, and 34011515A, exp 06/14. Class II Failed Dissolution Specifications: Product is being recalled due to out of specification dissolution results obtained during routine stability testing. 7,579 bottles D-849-2013
Methylphenidate Hydrochloride Extended-Release Capsules (LA), 30 mg, 100 count bottle, Rx only, TEVA PHARMACEUTICALS USA, NDC 0093-5347-01 34010290A, 34010291A, 34010292A, exp 04/14, 34011855A, 34011856A, 34011857A, 34011858A, 34013216A, 34013217A, 34013218A, exp 06/14. Class II Failed Dissolution Specifications: Product is being recalled due to out of specification dissolution results obtained during routine stability testing. 13,478 bottles D-848-2013
Methylphenidate Hydrochloride Extended-Release Capsules (LA), 20 mg, 100 count bottle, Rx only, TEVA PHARMACEUTICALS USA, NDC 0093-5346-01 34010282A, 34010283A, 34010284A, 34010285A, 34010286A and 34010565A, exp 04/14; 34013199A, 34013200A, 34013201A, 34013202A and 34013203A, exp 10/14. Class II Failed Dissolution Specifications: Product is being recalled due to out of specification dissolution results obtained during routine stability testing. 16,293 bottles D-847-2013
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