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U.S. Department of Health and Human Services

Class 2 Device Recall KY TINGLING JELLY Personal Lubricant.

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 Class 2 Device Recall KY TINGLING JELLY Personal Lubricant.see related information
Date Initiated by FirmJanuary 25, 2013
Date PostedFebruary 22, 2013
Recall Status1 Terminated 3 on April 11, 2014
Recall NumberZ-0875-2013
Recall Event ID 64322
Product Classification Lubricant, personal - Product Code NUC
ProductKY TINGLING JELLY Personal Lubricant. The product is packaged into 5 oz tubes with the UPC printed on it. Distributed By: McNeil-PPC Inc.
Code Information Tube UPC: 380040088887 Case Code(s): 008888 V21, 008888 V00 Outer Case UPC: 103800400888840215, 103800400888840000
Recalling Firm/
Manufacturer		 Mc-NEIL-PPC, Inc.
199 Grandview Rd
Skillman NJ 08558-1311
For Additional Information ContactStericycle
866-201-9138
Manufacturer Reason
for Recall		This product is not cleared for marketing in the US.
FDA Determined
Cause 2		No Marketing Application
ActionJohnson 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 Commerce425,304 units
DistributionNationwide Distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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