FDA recall D-0007-2016

Product

Vytorin (ezetimibe and simvastatin) tablets, 10 mg/20 mg, each tablet contains 10 mg ezetimibe and 20 mg simvastatin, Rx Only, 1000 count Bottle, Manuf. For Merck Sharp & Dohme Corp, a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ 08889, NDC 66582-0312-82.

Reason for recall

Presence of Foreign Tablet/Capsule: Vytorin 10 mg/40 mg tablets were found in bottles of Vytorin 10 mg/20 mg tablets.

Distribution

KY, MS and OH.

Key facts

Status

Terminated

Initiation date

2015-08-14

Report date

2015-10-14

Termination date

2016-05-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Wilson, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0007-2016