FDA Recalls Monistat 1 Simple Cure for Missing Topical Cream
Medtech Products, Inc. is recalling Monistat 1 Simple Cure because the distributed units lack the required topical cream.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, which is defined as a situation where use of or exposure to a violative product is not likely to cause adverse health consequences.
Plain-English summary
Medtech Products, Inc. is recalling Monistat 1 Simple Cure (Miconazole Nitrate) vaginal inserts. The recall involves 4,175 cases (50,100 ovules) and 6 cases (72 ovules) distributed as company samples. The affected product is identified by Lot # R18193 with an expiration date of 10/2016.
The recall was initiated because the distributed units were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). Specifically, the distributed units included only the 1200 mg vaginal suppository, whereas the approved NDA requires the product to include both the 1200 mg vaginal suppository and the 2% topical cream.
The product was distributed nationwide. Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- MONISTAT 1 COMBINATION PACK (MICONAZOLE NITRATE)
- Brand
- MONISTAT 1 COMBINATION PACK
- Manufacturer
- Medtech Products, Inc.
- Category
- Drug — OTC Vaginal Antifungal
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot#: R18193
- Exp 10/2016
Distribution
Distributed nationwide across the United States.
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