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Recall Observatory FDA recall evidence

Device 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.

Z-0874-2013

January 25, 2013

Class II

Product summary

Firm
Mc-NEIL-PPC, Inc.
Event
Event 64322
Status
Terminated
Classification
Class II
Quantity
750,264 units
Official record key
device-enforcement:Z-0874-2013

Official wording

Reason: This product is not cleared for marketing in the US.

Code information: Carton: 380040087149 Case Code: 008714 V05 Outer case UPC Code: 103800400871460055 Outer case Display UPC Code: 00380041153300

Distribution pattern: Nationwide Distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    This product is not cleared for marketing in the US.