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U.S. Department of Health and Human Services

Enforcement Report - Week of March 6, 2013

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Product Detail

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.
Recall Number Z-0874-2013
Classification Class II
Code Info Carton: 380040087149 Case Code: 008714 V05 Outer case UPC Code: 103800400871460055 Outer case Display UPC Code: 00380041153300
Product Distributed Qty 750,264 units
Reason For Recall This product is not cleared for marketing in the US.

Event Detail

Event Id 64322
Product Type Devices
Status Ongoing
Recalling Firm Mc-NEIL-PPC, Inc.
City Skillman
State NJ
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-01-25
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide Distribution.