Recall Z-0874-2013
Mc-NEIL-PPC, Inc. · initiated January 25, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: Carton: 380040087149 Case Code: 008714 V05 Outer case UPC Code: 103800400871460055 Outer case Display UPC Code: 00380041153300
Reason for recall
This product is not cleared for marketing in the US.
FDA-determined cause: No Marketing Application
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.
Details
- Recall number
- Z-0874-2013
- Initiated
- January 25, 2013
- Posted by FDA
- February 22, 2013
- Terminated
- April 11, 2014
- Product code
- NUC – Lubricant, Personal
- Quantity
- 750,264 units
- Distribution
- Nationwide Distribution.
- Recalling firm
- Mc-NEIL-PPC, Inc., Skillman, NJ
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0873-2013 Class II | KY SENSITIVE TM JELLY Personal Lubricant. The product is packaged into 3 oz tubes, which…This product is not cleared for marketing in the US. | 01/25/2013Terminated |
| Z-0875-2013 Class II | KY TINGLING JELLY Personal Lubricant. The product is packaged into 5 oz tubes with the…This product is not cleared for marketing in the US. | 01/25/2013Terminated |