KY SilkE Vaginal Moisturizer and Personal Lubricant. The product is packaged in 2.5 oz bottles, which are then packed in

FDA device recall Z-0874-2013 · posted 2013-02-22 · Terminated

Recall details

Recalling firm

Mc-NEIL-PPC, Inc.

Reason for recall

This product is not cleared for marketing in the US.

Action taken

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

Status

Terminated

Product code

NUC

Quantity affected

750,264 units

Distribution

Nationwide Distribution.

Date initiated

2013-01-25

Date posted

2013-02-22

Date terminated

2014-04-11

Location

Skillman, NJ