FDA recall D-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

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

Nationwide and Puerto Rico

Key facts

Status

Terminated

Initiation date

2014-01-13

Report date

2014-05-14

Termination date

2015-09-02

Voluntary/Mandated

Voluntary: Firm initiated

Location

Whitehouse Station, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1312-2014