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Recall Observatory FDA recall evidence

Food 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

F-0058-2019

September 20, 2018

Class II

Product summary

Firm
Tarry Medical Products, Inc.
Event
Event 81082
Status
Terminated
Classification
Class II
Quantity
46 cases (17664 vials)
Official record key
food-enforcement:F-0058-2019

Official wording

Reason: Microorganism found inside vial.

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

Distribution pattern: Direct to PA, WI, OH, GA, NE, CA

Derived failure modes

  • Microbial contamination

    reason.microbial_contamination · v1.0.0

    Microorganism found