CLASS III Drug recall · Reported 20 May 2015 · FDA Enforcement Report
Monistat 1 Simple Cure (Miconazole Nitrate Vaginal Insert) recalled
Medtech Products is recalling Monistat 1 Simple Cure (Miconazole Nitrate Vaginal Insert) 1200 mg ovule, 1-Day Maximum, distributed nationwide in the US. The recall was initiated on 10 Apr 2015 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1077-2015
- FDA event ID
- 70932
- Recalling firm
- Medtech Products, Tarrytown, NY
- Manufacturer
- Insight Pharmaceuticals LLC
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 10 Apr 2015
- FDA classified
- 13 May 2015
- Reported
- 20 May 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
Timeline
| 10 Apr 2015 | Recall initiated by company | |
| 13 May 2015 | Classified by FDA | +33 days |
| 20 May 2015 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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
Where it was distributed
Nationwide
Questions about this recall
Why was it 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 lots are affected?
Lot#: R18193, Exp 10/2016
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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