D-1077-2015 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- May 20, 2015
- Initiation Date
- April 10, 2015
- Termination Date
- March 3, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4,175 cases (50,100 ovules); and 6 cases (72 ovules) as company samples
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.
Distribution Pattern
Nationwide
Code Information
Lot#: R18193, Exp 10/2016