FDA Drug recall D-1077-2015
MONISTAT 1 SIMPLE CURE (Miconazole Nitrate Vaginal Insert) 1200 mg ovule, 1-DAY MAXIMUM STRENGTH TREATMENT OVULE per case, over-the-counter…
- FDA Drug
- Class III
- terminated
- Published 2015-05-20
On 2015-05-20 the FDA classified a Class III recall of MONISTAT 1 SIMPLE CURE (Miconazole Nitrate Vaginal Insert) 1200 mg ovule, 1-DAY MAXIMUM STRENGTH TREATMENT OVULE per case, over-the-counter… by Medtech Products, citing 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 vagin….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1077-2015 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2015-04-10 |
| Published | 2015-05-20 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Medtech Products |
| Distribution | US |
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
Reason
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.
Identifiers
| ndc | 63736-013-30 |
|---|---|
| code_info | Lot#: R18193, Exp 10/2016 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1077-2015%22
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