Recall Z-0873-2013

Mc-NEIL-PPC, Inc. · initiated January 25, 2013

Class II Terminated

Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature

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.

Codes / lots: 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

Reason for recall

This product is not cleared for marketing in the US.

FDA-determined cause: No Marketing Application

Action taken

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.

Details

Recall number
Z-0873-2013
Initiated
January 25, 2013
Posted by FDA
February 22, 2013
Terminated
April 11, 2014
Product code
NUC – Lubricant, Personal
Quantity
1,185,664 units
Distribution
Nationwide Distribution.
Recalling firm
Mc-NEIL-PPC, Inc., Skillman, NJ

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-0874-2013 Class IIKY SilkE Vaginal Moisturizer and Personal Lubricant. The product is packaged in 2.5 oz…This product is not cleared for marketing in the US. 01/25/2013Terminated
Z-0875-2013 Class IIKY TINGLING JELLY Personal Lubricant. The product is packaged into 5 oz tubes with the…This product is not cleared for marketing in the US. 01/25/2013Terminated