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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 64322

3 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
January 25, 2013
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Mc-NEIL-PPC, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

3 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 3

KY SENSITIVE TM JELLY Personal Lubricant. The product is packaged into 3 oz tubes, which are then packed into a printed carton. Distributed by McNeil-PPC Inc.

Z-0873-2013
Recall number
Z-0873-2013
Initiated
January 25, 2013
Classification
Class II
Status
Terminated
Recalling firm
Mc-NEIL-PPC, Inc.
Quantity
1,185,664 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
This product is not cleared for marketing in the US.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

No Marketing Application

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

This product is not cleared for marketing in the US.

Code information

Tube UPC: 380040085503 Case Code(s): 008550 V21, 008550 V00 Outer case UPC Code: 103800400855000215 Outer case UPC Code: 103800400855000000 Outer case Display UPC Code: 00380041153300

Distribution pattern

Nationwide Distribution.

device · product 2 of 3

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
Recall number
Z-0874-2013
Initiated
January 25, 2013
Classification
Class II
Status
Terminated
Recalling firm
Mc-NEIL-PPC, Inc.
Quantity
750,264 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
This product is not cleared for marketing in the US.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

No Marketing Application

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

device · product 3 of 3

KY TINGLING JELLY Personal Lubricant. The product is packaged into 5 oz tubes with the UPC printed on it. Distributed By: McNeil-PPC Inc.

Z-0875-2013
Recall number
Z-0875-2013
Initiated
January 25, 2013
Classification
Class II
Status
Terminated
Recalling firm
Mc-NEIL-PPC, Inc.
Quantity
425,304 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
This product is not cleared for marketing in the US.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

No Marketing Application

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

This product is not cleared for marketing in the US.

Code information

Tube UPC: 380040088887 Case Code(s): 008888 V21, 008888 V00 Outer Case UPC: 103800400888840215, 103800400888840000

Distribution pattern

Nationwide Distribution.