Class IIFDACA, GA, IA, MA +5
Tarry Medical Products, Inc. recalls DandleLION Kisses, 24% Sterile Organic Sucrose In Purified Water, 2 ml polyethylene vial. (Class II)
Microbial contamination
Class IIFDAF-0058-2019
Tarry Medical Products, Inc. recalls Product comes in a plastic bag which is labeled as follows: DandleLION MEDICAL DandleLION (Class II)
Class II — Eating this product may cause temporary or medically reversible health problems; serious harm is unlikely.
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.
Affected products (1)
| Recall # | Product | Lot / code | Status |
|---|---|---|---|
| F-0058-2019 | 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 | Lot/Unit Numbers: DUP Manufacturer's Batch Code: F17272 | Terminated |
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