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U.S. Department of Health and Human Services

Enforcement Report - Week of February 6, 2013

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Product Detail

Product Description Carvedilol Tablets, USP, 12.5 mg, 500-count tablets per bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-3633-05, UPC 3 0378-3633-05 3.
Recall Number D-137-2013
Classification Class II
Code Info Lot #: ZCMH12031, ZCMH12032, ZCMH12033, ZCMH12034, Exp 02/14
Product Distributed Qty 11,580 bottles
Reason For Recall Failed Tablet/Capsule Specifications: Product exceeds specification for tablet weight and tablet thickness.

Event Detail

Event Id 64154
Product Type Drugs
Status Ongoing
Recalling Firm Mylan Pharmaceuticals Inc.
City Morgantown
State WV
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-01-16
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide.