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Recall Observatory FDA recall evidence

Drug 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

D-1077-2015

April 10, 2015

Class III

Product summary

Firm
Medtech Products, Inc.
Event
Event 70932
Status
Terminated
Classification
Class III
Quantity
4,175 cases (50,100 ovules); and 6 cases (72 ovules) as company samples
Official record key
drug-enforcement:D-1077-2015

Official wording

Reason: 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.

Code information: Lot#: R18193, Exp 10/2016

Distribution pattern: Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.