Home / Tarry Medical Products, Inc. / F-0058-2019
Class II
Tarry Medical Products, Inc.
Recall #F-0058-2019 · Initiated 2018-09-20
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.
Quantity affected
46 cases (17664 vials)
Distribution
Direct to PA, WI, OH, GA, NE, CA
Lot / code info
Lot/Unit Numbers: DUP Manufacturer's Batch Code: F17272
Voluntary / mandated
Voluntary: Firm initiated
Initial notification
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Terminated
2018-11-29
Recalling firm
Tarry Medical Products, Inc.
22 Shelter Rock Ln Ste 36
Danbury, CT 06810-8267
United States
Recall classification
Remote probability of serious adverse health consequences, or temporary reversible consequences.