Recalls / Class III

Class IIID-1310-2014

Product

Liptruzet (ezetimibe and atorvastin) tablets,10 mg/20 mg, a) 30 count blister (NDC 66582-321-30), b) 90 count blister (NDC 66582-321-54), Rx only, Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc, Whitehouse Station, NJ 08889

Affected lot / code info

a) Liptruzet 10/20mg 30 count, 346353, 346354, Exp. 06/14; 351809, Exp. 07/14, 360530, Exp. 12/14. b) Liptruzet 10/20mg, 90 count, 346387, Exp. 06/14; 353185, Exp.12/14.

Why it was recalled

This recall of LIPTRUZET is being initiated due to packaging defects. 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

20,259 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-1310-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.