D-1312-2014 Class III Terminated

Recalled by Merck & Co Inc — Whitehouse Station, NJ

Recall Details

Product Type
Drugs
Report Date
May 14, 2014
Initiation Date
January 13, 2014
Termination Date
September 2, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
11,462 cartons

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

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.

Distribution Pattern

Nationwide and Puerto Rico

Code Information

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.