FDA-Food2018-10-24Class II

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

Hazard

Microorganism found inside vial.

Sold states
Direct to PA, WI, OH, GA, NE, CA
Affected count
46 cases (17664 vials)
Manufactured in
22 Shelter Rock Ln Ste 36, N/A, Danbury, CT, United States
Products
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

Official notice

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

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