FDA Device

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.

Hazard

This product is not cleared for marketing in the US.

What You Should Do

Remedy

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.

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Products

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.
Brand
Mc-NEIL-PPC, Inc.
UPC
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

Units Affected

1,185,664 units

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