KY LIQUIBEADS Vaginal Moisturizer; Distributed By: McNeil-PPC, Inc. Skillman, NJ 08558-9418; UPC 380041087704; 380040087

FDA device recall Z-2467-2012 · posted 2012-09-27 · Terminated

Recall details

Recalling firm

Mc-NEIL-PPC, Inc.

Reason for recall

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 thi

Action taken

Johnson & Johnson sent Recall Letters/Response forms dated June 29, 2012 on July 2, 2012. The recall notification included affected lots and instructions for wholesale distributors and retailers that handle the product. The recalled product is being handled by Stericycle. The notification included phone and fax numbers in the event assistance is required. Customers were asked to complete the enclosed business Reply Form and return immediately; identify all warehouse/wholesale inventories of products and return immediately per the attached "Return Authorization Form." For any questions regarding the form, customers were asked to call Stericycle at 888-406-9309. Customers could also fax questions to 877-877-0318. Once customers have collected all returns, they should send back immediately per the enclosed instructions. For questions regarding this recall call 908-874-1000.

Root cause

No Marketing Application

Status

Terminated

Product code

NUC

Quantity affected

818,712

Distribution

Nationwide Distribution

Date initiated

2012-07-02

Date posted

2012-09-27

Date terminated

2013-09-27

Location

Skillman, NJ