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U.S. Department of Health and Human Services

Enforcement Report - Week of May 14, 2014

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Product Detail

Product Description Liptruzet (ezetimibe and atorvastin) tablets,10 mg/80 mg, a) 30 count blister (NDC 66582-323-30), b) 90 count blister (NDC 66582-323-54), Rx only, Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc, Whitehouse Station, NJ 08889
Recall Number D-1312-2014
Classification Class III
Code Info a) Liptruzet 10/80mg 30 count, 346379, 350257, Exp.07/14; 353591, Exp. 06/15. b) Liptruzet 10/80mg 90 count, 346383, 371072, Exp. 06/15.
Product Distributed Qty 11,462 cartons
Reason For Recall Defective Container; some of the outer laminate foil pouches allowed in air and moisture, which could potentially decrease the effectiveness or change the characteristics of the product.

Event Detail

Event Id 67344
Product Type Drugs
Status Ongoing
Recalling Firm Merck & Co Inc
City Whitehouse Station
State NJ
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-01-13
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern Nationwide and Puerto Rico