Recall Z-0873-2013— Mc-NEIL-PPC, Inc.

Class II · Terminated

Class II FDA medical device recall by Mc-NEIL-PPC, Inc., initiated 2013-01-25, terminated 2014-04-11. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: This product is not cleared for marketing in the US..

Recalling firm
Mc-NEIL-PPC, Inc.
Classification
Class II
Status
Terminated
Initiated
2013-01-25
Terminated
2014-04-11
Firm location
Skillman, NJ, United States

Product description

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.

Reason for recall

This product is not cleared for marketing in the US.

Data sourced from openFDA. This site is unofficial and independent of the FDA.