Drug recall D-1077-2015

Class III Terminated reported May 20, 2015

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

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.

Lots and codes

Lot#: R18193, Exp 10/2016

Recall details

Recalling firm
Medtech Products, Inc., Tarrytown, NY
Quantity
4,175 cases (50,100 ovules); and 6 cases (72 ovules) as company samples
Distribution
Nationwide
Type
Voluntary: Firm initiated
Recall initiated
April 10, 2015
Terminated
March 3, 2016

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