Recall Z-2467-2012 ยท NUC Lubricant, Personal
Mc-NEIL-PPC, Inc.
KY LIQUIBEADS Vaginal Moisturizer; Distributed By: McNeil-PPC, Inc. Skillman, NJ 08558-9418; UPC 380041087704; 380040087958. Personal lubricant
| Date | Sep 27, 2012 (initiated Jul 2, 2012) |
| Status | Terminated |
| Reason | 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 |
| Root cause | No Marketing Application |
| Action | 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 reg |
| Quantity | 818,712 |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.