Recall Z-0874-2013— Mc-NEIL-PPC, Inc.
Class II · Terminated
Class II FDA medical device recall by Mc-NEIL-PPC, Inc., initiated 2013-01-25, terminated 2014-04-11. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: This product is not cleared for marketing in the US..
- Recalling firm
- Mc-NEIL-PPC, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-01-25
- Terminated
- 2014-04-11
- Firm location
- Skillman, NJ, United States
Product description
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.
Reason for recall
This product is not cleared for marketing in the US.
Data sourced from openFDA. This site is unofficial and independent of the FDA.