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.
FDA Recall Z-0874-2013 · Posted 2013-02-22
Recalling FirmMc-NEIL-PPC, Inc.
Recall StatusTerminated
Product CodeNUC
Date Initiated2013-01-25
Date Terminated2014-04-11
Product Quantity750,264 units
Reason for Recall
This product is not cleared for marketing in the US.
Firm 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.
Root Cause
No Marketing Application
Distribution Pattern
Nationwide Distribution.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.