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U.S. Department of Health and Human Services

Enforcement Report - Week of October 22, 2014

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Product Detail

Product Description Vaseretic (enalapril maleate/hydrochlorothiazide) 10/25 mg Tablets, NDC 0187-0146-01, 100 ct. bottles manufactured at Valeant Pharmaceuticals International, Inc., Steinbach, MD R5G 1Z7 Canada
Recall Number D-0018-2015
Classification Class III
Code Info VASERETIC 10-25MG TAB 100CT Lot # 12J022P exp. 9/30/2014 VASERETIC 10-25MG TAB 100CT Lot # 13G047P exp. 07/31/2015
Product Distributed Qty 205,853 bottles
Reason For Recall Labeling: Incorrect or Missing Package Insert: Product is packaged with the incorrect version of the package outset

Event Detail

Event Id 68572
Product Type Drugs
Status Ongoing
Recalling Firm Valeant Pharmaceuticals North America LLC
City Bridgewater
State NJ
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-05-21
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide
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