Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0875-2013Class II

KY TINGLING JELLY Personal Lubricant. The product is packaged into 5 oz tubes with the UPC printed on it...

Kenvue Brands LLC / initiated 2013-01-25 / Terminated

Mc-NEIL-PPC, Inc. began a recall of KY TINGLING JELLY Personal Lubricant. The product is packaged into 5 oz tubes with the UPC printed on it. Distributed By: McNeil-PPC Inc on . FDA classified it as Class II and gives the reason as "This product is not cleared for marketing in the US". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0875-2013
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Kenvue Brands LLC
Product
KY TINGLING JELLY Personal Lubricant. The product is packaged into 5 oz tubes with the UPC printed on it. Distributed By: McNeil-PPC Inc.
Product code
NUC Lubricant, Personal
Reason for recall
This product is not cleared for marketing in the US.
FDA 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 in commerce
425,304 units
Distribution
Nationwide Distribution.
Product codes and lots
Tube UPC: 380040088887 Case Code(s): 008888 V21, 008888 V00 Outer Case UPC: 103800400888840215, 103800400888840000

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-0875-2013
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-0873-2013Class IITerminatedVoluntary: Firm initiated
Z-0874-2013Class IITerminatedVoluntary: Firm initiated
Z-0875-2013Class IITerminatedVoluntary: Firm initiated