April 2015 FDA Recall Monistat 1 Combination Pack by Medtech Products, Inc.
D-1077-2015 - Marketed without an approved NDA/ANDA

This Class III drug recall was voluntarily initiated by Medtech Products, Inc. on April 10, 2015 for the product Monistat 1 Combination Pack. The FDA reported the reason for recall as marketed without an approved nda/anda. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1077-2015

Reason for Recall
Marketed without an approved NDA/ANDA: The distributed units of Monistat 1 Simple Cure include only the 1200 mg vaginal suppository; the approved NDA requires both a 1200 mg vaginal suppository and the 2% topical cream.
Initiated
04-10-2015
Reported
05-20-2015
Quantity
4,175 cases (50,100 ovules); and 6 cases (72 ovules) as company samples

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
70932
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Medtech Products, Inc.
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.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-03-2016
Product Description About Product Description
Full technical description of the product.
MONISTAT 1 SIMPLE CURE (Miconazole Nitrate Vaginal Insert) 1200 mg ovule, 1-DAY MAXIMUM STRENGTH TREATMENT OVULE per case, over-the-counter, Distributed by INSIGHT Pharmaceuticals, LLC, Trevose, PA 19053-8433, NDC 63736-013-30

Batch or Lot Expiration Information

Lot# : R18193, Exp 10/2016

Affected Packages Involved in this Recall

63736-013-30 Monistat 1 Combination Pack