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U.S. Department of Health and Human Services

Class 2 Device Recall KY SilkE Vaginal Moisturizer and Personal Lubricant

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 Class 2 Recall
KY SilkE Vaginal Moisturizer and Personal Lubricant
see related information
Date Posted February 22, 2013
Recall Status1 Terminated on April 11, 2014
Recall Number Z-0874-2013
Recall Event ID 64322
Product Classification Lubricant, Personal - Product Code NUC
Product 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.
Code Information Carton: 380040087149 Case Code: 008714 V05 Outer case UPC Code: 103800400871460055 Outer case Display UPC Code: 00380041153300
Recalling Firm/
Manufacturer
Mc-NEIL-PPC, Inc.
199 Grandview Rd
Skillman, New Jersey 08558-1311
For Additional Information Contact Stericycle
866-201-9138
Manufacturer Reason
for Recall
This product is not cleared for marketing in the US.
FDA Determined
Cause 2
PREMARKET APPROVAL: 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 750,264 units
Distribution Nationwide Distribution.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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