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
This recall has been terminated (originally issued October 24, 2018).
- Company
- Tarry Medical Products, Inc.
- Recall Initiated
- September 20, 2018
- Posted
- October 24, 2018
- Recall Number
- F-0058-2019
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 46 cases (17664 vials)
- Firm Location
- Danbury, CT, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Microorganism found inside vial.
Distribution
Direct to PA, WI, OH, GA, NE, CA
Lot / Code Info
Lot/Unit Numbers: DUP Manufacturer's Batch Code: F17272
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