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Mia Vita

FEMMEPHARMA CONSUMER HEALTHCARE LLC · Model 01 · UDI-DI 00850035529003

NUC
1
510(k) clearances
175
Adverse events (1 deaths)
7
Recalls
125
Facilities

Description

Mia Vita vaginal moisturizer and personal lubricant is a non-sterile, water-based, white to off-white, non-irritating, non-greasy, non-staining low volume gel delivered in a single use disposable applicator for vaginal dryness. The applicator provides convenience and provides for less mess during application. Mia Vita vaginal moisturizer and personal lubricant is intended for ongoing use, not exclusively for use during intimate sexual activity. Mia Vita vaginal moisturizer and personal lubricant contains ingredients commonly used in other products for intravaginal use sold as medical devices and cosmetics. All ingredients used are approved high quality pharmaceutical grade, and considered "generally recognized as safe for their intended use" by the FDA. The quantitative formulation is considered confidential commercial information.

Recalls

DateFirmReason
2022-06-23Family Dollar Stores, Llc.Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022.
2013-01-25Mc-NEIL-PPC, Inc.This product is not cleared for marketing in the US.
2013-01-25Mc-NEIL-PPC, Inc.This product is not cleared for marketing in the US.
2013-01-25Mc-NEIL-PPC, Inc.This product is not cleared for marketing in the US.
2012-07-02Mc-NEIL-PPC, Inc.Johnson & Johnson Healthcare Products (JJHP) is voluntarily recalling this product to address FDA concerns that the product should have been cleared under a separate medical device
2009-07-10Memphis Fertility Laboratory IncProduct was marketed without a 510(k).
2008-09-22INGfertility, LLCProduct contaminated with bacteria (Brachybacterium rhamnosum, a non pathogen gram positive cocci).

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.