Class IITerminated in FDA datasetRecall initiated Sep 20, 2018

Product comes in a plastic bag which is labeled as follows: DandleLION MEDICAL DandleLION…

Recalling firm: Tarry Medical Products, Inc.

Why it was recalled

Microorganism found inside vial.

Historical recall record. This is not a new recall announcement. “Terminated” describes the FDA recall process; it does not certify that an individual package is safe. FDA termination date: Nov 29, 2018.

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Compare the exact product and package details with the label you have.

ProductProduct 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
Package size2mL

FDA code information

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

Match the product, package size, and code together. A missing match does not guarantee safety.

Full FDA record and distribution details

Original product description

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

Extracted codes and context

TypeCode / valueContext
batchF17272Lot/Unit Numbers: DUP Manufacturer's Batch Code: F17272

Original FDA recall reason

Microorganism found inside vial.

Recall details

Recall number
F-0058-2019
Event ID
81082
FDA status
Terminated
Initiated
Sep 20, 2018
Reported
Oct 24, 2018
Classified
Oct 22, 2018
Terminated
Nov 29, 2018
Quantity
46 cases (17664 vials)
Location
Danbury, CT, United States
Initiation type
Voluntary: Firm initiated
Notification
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Where it was distributed

Direct to PA, WI, OH, GA, NE, CA

FDA source record · F-0058-2019

Data updated September 16, 2026. View official FDA data ↗

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