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
Reported: May 20, 2015 Initiated: April 10, 2015 #D-1077-2015
Product Description
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.
Details
- Recalling Firm
- Medtech Products, Inc.
- Units Affected
- 4,175 cases (50,100 ovules); and 6 cases (72 ovules) as company samples
- Distribution
- Nationwide
- Location
- Tarrytown, NY
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Medtech Products, Inc.. Units affected: 4,175 cases (50,100 ovules); and 6 cases (72 ovules) as company samples.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 20, 2015. Severity: Low. Recall number: D-1077-2015.
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