Mc-NEIL-PPC, Inc.: Medical Device Recall in 2013 - (Recall #: Z-0874-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

KY SilkE Vaginal Moisturizer and Personal Lubricant. The product is packaged in 2.5 oz bottles, which are then packed into a printed carton. Distributed by McNeil-PPC Inc.

Product Classification:

Class II

Date Initiated: January 25, 2013

Date Posted: March 6, 2013

Recall Number: Z-0874-2013

Event ID: 64322

Reason for Recall:

This product is not cleared for marketing in the US.

Status: Terminated

Product Quantity: 750,264 units

Code Information:

Carton: 380040087149 Case Code: 008714 V05 Outer case UPC Code: 103800400871460055 Outer case Display UPC Code: 00380041153300

Distribution Pattern:

Nationwide Distribution.

Voluntary or Mandated:

Voluntary: Firm initiated