FDA recall F-0058-2019

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) 24% ORGANIC SUCROSE SOLUTION ORANGE VIAL QTY - 384

Reason for recall

Microorganism found inside vial.

Distribution

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

Key facts

Status

Terminated

Initiation date

2018-09-20

Report date

2018-10-24

Termination date

2018-11-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Danbury, CT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=F-0058-2019