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U.S. Department of Health and Human Services

Enforcement Report - Week of October 3, 2012

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Event Detail

Event ID 62948
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 2012-07-02
Initial Firm Notification of
Consignee or Public
Distribution Pattern Nationwide Distribution

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
KY LIQUIBEADS Vaginal Moisturizer; Distributed By: McNeil-PPC, Inc. Skillman, NJ 08558-9418; UPC 380041087704; 380040087958. Personal lubricant The following Lot Numbers were identified: 2721W; 2591W; 2321W; 1681W; 0921W; 0651W; 0471W; 0361W; 0221W; 0041W; 0110H; 0100H; 0090H; 0080H; 0030H; 0179H; 0159H; 0219H and 3489RT. Class II Johnson & Johnson Healthcare Products (JJHP) is voluntarily recalling this product to address FDA concerns that the product should have been cleared under a separate medical device application. This voluntary recall is not being conducted on the basis of any consumer safety or product performance issues related to K-Y LIQUIBEADS. JJHP received a Warning Letter on May 23, 2012 indicating that this device, KY Liquibeads Vaginal Moisturizer, is misbranded under the section 502(o) the Act, 21 U.S.C. 352(o), because we did not notify the agency of our intent to introduce the device into commercial distribution, as required by 510(k) of the Act, U.S.C. 360(k). The Warning Letter indicated that changes were made to the predicate device that would require submission of a new 510(k). 818,712 Z-2467-2012