Recalls / Class III
Class IIID-1077-2015
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
- Brand name
- Monistat 1 Combination Pack
- Generic name
- Miconazole Nitrate
- NDC
- 63736-013
- FDA application
- NDA021308
- Affected lot / code info
- Lot#: R18193, Exp 10/2016
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.
Recalling firm
- Firm
- Medtech Products, Inc.
- Manufacturer
- Insight Pharmaceuticals LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 660 White Plains Rd, N/A, Tarrytown, New York 10591-5139
Distribution
- Quantity
- 4,175 cases (50,100 ovules); and 6 cases (72 ovules) as company samples
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2015-04-10
- FDA classified
- 2015-05-13
- Posted by FDA
- 2015-05-20
- Terminated
- 2016-03-03
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1077-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.