Recalls / Class III

Class IIID-1312-2014

Product

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

Affected lot / 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.

Why it was recalled

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.

Recalling firm

Firm

Merck & Co Inc

Notification channel

Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Type

Voluntary: Firm initiated

Address

1 Merck Dr, P.O. Box 100, Whitehouse Station, New Jersey 08889-3400

Distribution

Quantity

11,462 cartons

Distribution pattern

Nationwide and Puerto Rico

Timeline

Recall initiated

2014-01-13

FDA classified

2014-05-06

Posted by FDA

2014-05-14

Terminated

2015-09-02

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-1312-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.