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Gynatrof(R)
Tyros Biopharma Inc · Model 15 mL · UDI-DI 00180266000041
10
510(k) clearances
175
Adverse events (1 deaths)
7
Recalls
126
Facilities
Description
Gynatrof is a personal lubricant, for vaginal and/or penile application, intended to moisturize and lubricate, to enhance the easeand comfort of intimate sexual activity and supplement the body’s natural lubrication.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-06-23 | Family Dollar Stores, Llc. | Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022. |
| 2013-01-25 | Mc-NEIL-PPC, Inc. | This product is not cleared for marketing in the US. |
| 2013-01-25 | Mc-NEIL-PPC, Inc. | This product is not cleared for marketing in the US. |
| 2013-01-25 | Mc-NEIL-PPC, Inc. | This product is not cleared for marketing in the US. |
| 2012-07-02 | Mc-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 |
| 2009-07-10 | Memphis Fertility Laboratory Inc | Product was marketed without a 510(k). |
| 2008-09-22 | INGfertility, LLC | Product contaminated with bacteria (Brachybacterium rhamnosum, a non pathogen gram positive cocci). |
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Get your free API keyRead the docsData 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.