August 2015 FDA Recall Drug by Merck Sharp & Dohme, Wilson Facility
D-0007-2016 - Presence of Foreign Tablet/Capsule

This Class II drug recall was voluntarily initiated by Merck Sharp & Dohme, Wilson Facility on August 14, 2015 for the product Drug. The FDA reported the reason for recall as presence of foreign tablet/capsule. The product was distributed in KY, MS and OH. and the recall is currently terminated.

Recall Number: D-0007-2016

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.
Initiated
08-14-2015
Reported
10-14-2015
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72324
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Merck Sharp & Dohme, Wilson Facility
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
KY, MS and OH.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-04-2016
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

Lot# Lot number: L013425, Exp. 11/2016