Why it was 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.
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
Lot numbers, UPCs & expiration codes
Lot#: R18193, Exp 10/2016
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1077-2015
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Apr 10, 2015
- FDA report date
- May 20, 2015
- Quantity
- 4,175 cases (50,100 ovules); and 6 cases (72 ovules) as company samples
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Medtech Products, Inc.
Original FDA data
Every field from FDA enforcement report D-1077-2015, exactly as published.
Show all FDA fields
- City
- Tarrytown
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 70932
- Address
- 660 White Plains Rd
- Code information
- Lot#: R18193, Exp 10/2016
- Postal code
- 10591-5139
- Report date
- May 20, 2015
- Product type
- Drugs
- Recall number
- D-1077-2015
- Classification
- Class III
- Recalling firm
- Medtech Products, Inc.
- Product quantity
- 4,175 cases (50,100 ovules); and 6 cases (72 ovules) as company samples
- Termination date
- Mar 3, 2016
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide
- Recall initiation date
- Apr 10, 2015
- Initial firm notification
- Letter
- Center classification date
- May 13, 2015