FDA recall D-1310-2014

Merck & Co Inc · Class III · drug

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

Reason for recall

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.

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-1310-2014