KY SilkE Vaginal Moisturizer and Personal Lubricant — Class II medical device recall Z-0874-2013
Terminated recall by Mc-NEIL-PPC, Inc., reported 2013-03-06, distributed nationwide. This product is not cleared for marketing in the US.
| Recall number | Z-0874-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mc-NEIL-PPC, Inc., Skillman, NJ, United States |
| Recall initiated | 2013-01-25 |
| Classified | 2013-02-22 |
| Reported by FDA | 2013-03-06 |
| Terminated | 2014-04-11 |
| Distributed | Nationwide (US) |
| Quantity | 750,264 units |
| Reason classes | unapproved product |
| UPC / GTIN / UDI-DI | 00380040087149, 00380041153300 |
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 for recall
This product is not cleared for marketing in the US.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0874-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.