Medtech Products, Inc. recalls MONISTAT 1 SIMPLE CURE (Miconazole Nitrate Vaginal Insert) 1200 mg ovule, 1-DAY MAXIMUM STRENGTH TREATMENT OVULE per cas
Recalled May 20, 2015 · FDA recall D-1077-2015 · Medtech Products
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. · FDA Class III
Units
4,175 cases (50,100 ovules); and 6 cases (72 ovules) as company samples
Sold at
Nationwide
Description
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.
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
Manufacturer(s)
Medtech Products, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →