Medtech Products, Inc. recalls MONISTAT 1 SIMPLE CURE (Miconazole Nitrate Vaginal Insert) 1200 mg ovule, 1-DAY MAXIMUM STRENGTH TREATMENT OVULE per ca…

Recall date

April 10, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-1077-2015

FDA classification

Class III

Brand / firm

Medtech Products, Inc.

Sold / distributed

Nationwide

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.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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