FDA Medical Device Recalls (openFDA)
Mc-NEIL-PPC, Inc.: KY SENSITIVE TM JELLY Personal Lubricant. The product is packaged into 3 oz tubes, which are then packed into a printed carton. Distributed by McNeil-PPC Inc.
- Recall number
- Z-0873-2013
- Recalling firm
- Mc-NEIL-PPC, Inc.
- Product
- KY SENSITIVE TM JELLY Personal Lubricant. The product is packaged into 3 oz tubes, which are then packed into a printed carton. Distributed by McNeil-PPC Inc.
- Status
- Terminated
- Initiated
- 2013-01-25
- Posted
- 2013-02-22
- Terminated
- 2014-04-11
- Reason
- This product is not cleared for marketing in the US.
- Root cause
- No Marketing Application
- Action
- Johnson and Johnson Healthcare Products sent recall notification letters dated 1/25/2013 to its customers (retailers and wholesalers). The letter identified the product, problem, and actions to be taken by the customers. Customers were asked to return all cases of affected product in their possession. The letter included delivery confirmation and a return packing slip, return authorization label and business reply card. Contact J & J Sales & Logistics at 866-912-8414 for questions regarding the return of affected product. Contact your J & J Sales & Logistics Company Sales Representative for questions about the product.
- Quantity
- 1,185,664 units
- Distribution
- Nationwide Distribution.
- Lot, serial or model codes
- Tube UPC: 380040085503 Case Code(s): 008550 V21, 008550 V00 Outer case UPC Code: 103800400855000215 Outer case UPC Code: 103800400855000000 Outer case Display UPC Code: 00380041153300
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- NUC
- Firm FEI
- 2214133
- Firm city
- Skillman
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28