FDA-Drug2015-05-20Class III
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
Medtech Products, Inc.
Hazard
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.
Sold states
Nationwide
Affected count
4,175 cases (50,100 ovules); and 6 cases (72 ovules) as company samples
Manufactured in
660 White Plains Rd, N/A, Tarrytown, NY, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1077-2015Don't want to check this manually?
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