KY TINGLING JELLY Personal Lubricant Recalled for Lack of FDA Clearance
McNeil-PPC Inc. is recalling KY TINGLING JELLY Personal Lubricant because the product is not cleared for marketing in the US.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, which indicates a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The rubric assigns a score of 3 to risk-of-harm products where injury has not yet been reported, as no specific injuries or illnesses are mentioned in the source text.
Plain-English summary
McNeil-PPC Inc. is recalling KY TINGLING JELLY Personal Lubricant, packaged in 5 oz tubes, because the product is not cleared for marketing in the United States. The recall involves 425,304 units that were distributed nationwide.
The recall was initiated by the U.S. Food and Drug Administration (FDA) as a Class II recall. The specific reason for the recall is that the product lacks the necessary FDA clearance for marketing in the US.
Consumers who have this product should stop using it and contact McNeil-PPC Inc. for further instructions or a refund. The product is identified by the tube UPC 380040088887 and case codes 008888 V21 and 008888 V00.
The recalled product
- Product
- KY TINGLING JELLY Personal Lubricant. The product is packaged into 5 oz tubes with the UPC printed on it. Distributed By: McNeil-PPC Inc.
- Manufacturer
- Mc-NEIL-PPC, Inc.
- Hazard
- Affected units
- 425,304
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Tube UPC: 380040088887 Case Code(s): 008888 V21
- 008888 V00 Outer Case UPC: 103800400888840215
- 103800400888840000
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Mc-NEIL-PPC, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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