# FDA recall D-1077-2015

> **Medtech Products, Inc.** · Class III · drug recall initiated 2015-04-10.

## 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 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

Nationwide

## Key facts

- **Recall number:** D-1077-2015
- **Recalling firm:** Medtech Products, Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2015-04-10
- **Report date:** 2015-05-20
- **Termination date:** 2016-03-03

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Tarrytown, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1077-2015

## Citation

> AI Analytics. FDA recall D-1077-2015. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-1077-2015. Source: US FDA. Licensed CC0.

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