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

FDA recall notice · announced October 24, 2018 · Tarry Medical Products

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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.

Notes

Distribution: Direct to PA, WI, OH, GA, NE, CA
Lot/code information: Lot/Unit Numbers: DUP Manufacturer's Batch Code: F17272
Quantity: 46 cases (17664 vials)
Status: Terminated
Products in this recall event:
- 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 (F-0058-2019)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.