FDA (Devices) recall action 64322
The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.
This product is not cleared for marketing in the US.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
McNeil-PPC is recalling KY SilkE Vaginal Moisturizer because the product is not cleared for marketing in the US.
McNeil-PPC Inc. is recalling KY Sensitive Jelly Personal Lubricant because the product is not cleared for marketing in the US.
McNeil-PPC Inc. is recalling KY TINGLING JELLY Personal Lubricant because the product is not cleared for marketing in the US.