The Recall Desk
Agency classClass IIOur severity:HighFDA (Food)·F-0058-2019·Announced 2018-10-24

Tarry Medical Recalls DandleLION KISSES Due to Microorganism Contamination

Tarry Medical Products is recalling DandleLION KISSES oral sucrose solution because a microorganism was found inside the vials. The recall affects 46 cases distributed to six states.

The agency’s classification

FDA (Food): 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 and involves a high-risk contamination (microorganism) without reported illnesses, which aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Tarry Medical Products, Inc. is recalling 46 cases (17,664 vials) of DandleLION KISSES, a 24% organic sucrose solution intended for oral use. The recall was initiated because a microorganism was found inside the vials. The affected product is identified by Manufacturer's Batch Code F17272 and Lot/Unit Number DUP.

The recalled product was distributed directly to Pennsylvania, Wisconsin, Ohio, Georgia, Nebraska, and California. The product is packaged in plastic bags labeled "DandleLION MEDICAL DandleLION KISSES ORAL USE ONLY SINGLE PATIENT USE SINGLE APPLICATION 24% ORGANIC SUCROSE, D-12442 2mL." Case labeling indicates "DandleLION MEDICAL D 12242 C384 DandleLION KISSES (2ML) 24% ORGANIC SUCROSE SOLUTION ORANGE VIAL QTY - 384."

Consumers and healthcare providers should check their inventory for this specific batch code and discontinue use of the affected vials. The U.S. Food and Drug Administration has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Product comes in a plastic bag which is labeled as follows: DandleLION MEDICAL DandleLION KISSES ORAL USE ONLY SINGLE PATIENT USE SINGLE APPLICATION 24% ORGANIC SUCROSE, D-12442 2mL; The Product Case Labeling is as follows: DandleLION MEDICAL D 12242 C384 DandleLION KISSES (2ML)…
Manufacturer
Tarry Medical Products, Inc.
Category
Drug — Oral Solution
Hazard

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 (1)

  • Lot/Unit Numbers: DUP Manufacturer's Batch Code: F17272

Distribution

Distributed in 6 states:

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