Reported May 20, 2015 · Terminated
MONISTAT 1 SIMPLE CURE (Miconazole Nitrate Vaginal Insert) 1200 mg ovule, 1-DAY MAXIMUM STRENGTH TREATMENT OVULE per…
Medtech Products, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtech Products, Inc. · 660 White Plains Rd · Tarrytown, NY · 10591-5139
Is this the product you have?
- 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
- Lot codes and dates
Lot#: R18193Exp 10/2016
- Amount recalled
- 4,175 cases (50,100 ovules); and 6 cases (72 ovules) as company samples
Where it was sold
- Nationwide
Why it was recalled
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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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