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U.S. Department of Health and Human Services

Enforcement Report - Week of November 13, 2013

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Product Detail

Product Description Amlodipine Besylate and Benazepril HCl Capsules, 10 mg/40 mg, 100-count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-6900-01
Recall Number D-66403-010
Classification Class II
Code Info Lot #: 2003188, 2003189, 2003190, 2003191, 3043498
Product Distributed Qty 23,356 bottles
Reason For Recall CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.

Event Detail

Event Id 66403
Product Type Drugs
Status Ongoing
Recalling Firm Mylan Pharmaceuticals Inc.
City Morgantown
State WV
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-09-13
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide and Puerto Rico