PlainRecalls
FDA Food Moderate Class II Terminated

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

Reported: October 24, 2018 Initiated: September 20, 2018 #F-0058-2019

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

Reason for Recall

Microorganism found inside vial.

Details

Units Affected
46 cases (17664 vials)
Distribution
Direct to PA, WI, OH, GA, NE, CA
Location
Danbury, CT

Frequently Asked Questions

What product was recalled?
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.. Units affected: 46 cases (17664 vials).
Why was this product recalled?
Microorganism found inside vial.
Which agency issued this recall?
This recall was issued by the FDA Food on October 24, 2018. Severity: Moderate. Recall number: F-0058-2019.