MODERATE RISK Terminated F-0058-2019

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) 24% ORGANIC SUCROSE SOLUTION ORANGE VIAL QTY - 384

Recalled by Tarry Medical Products, Inc.

Classification

Class II — Products that might cause a temporary health problem, or pose only a slight threat of a serious nature.

Reason for Recall

Microorganism found inside vial.

Product Details

Product Quantity
46 cases (17664 vials)
Product Type
Food
Code Info
Lot/Unit Numbers: DUP Manufacturer's Batch Code: F17272
Voluntary/Mandated
Voluntary: Firm initiated

Distribution & Geography

Distribution Pattern
Direct to PA, WI, OH, GA, NE, CA
Company Location
Danbury, CT, 06810-8267

Timeline

Report Date
10/24/2018
Recall Initiated
09/20/2018
Classification Date
10/22/2018
Termination Date
11/29/2018

Source: U.S. Food & Drug Administration (FDA) — FDA Recalls

Last updated: August 29, 2026

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