Class II · Moderate riskTerminated Initiated Aug 14, 2015 (11 years ago)
Vytorin (ezetimibe and simvastatin) tablets, 10 mg/20 mg, each tablet contains 10 mg…
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Presence of Foreign Tablet/Capsule: Vytorin 10 mg/40 mg tablets were found in bottles of Vytorin 10 mg/20 mg tablets.
What was recalled
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.
Recalling firm
Merck Sharp & Dohme, Wilson Facility
NDC code
66582-0312-82
Origin
NC, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0007-2016
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Failed Impurities/Degradation Specifications: Out of Specification (OOS) for related substances test for Anhydro Simvastatin at the 06-month time…