Tarry Medical Recalls DandleLION KISSES Due to Microorganism Contamination
Tarry Medical Products is recalling DandleLION KISSES oral sucrose solution because a microorganism was found inside the vials. The recall affects 46 cases distributed to six states.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a high-risk contamination (microorganism) without reported illnesses, which aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Tarry Medical Products, Inc. is recalling 46 cases (17,664 vials) of DandleLION KISSES, a 24% organic sucrose solution intended for oral use. The recall was initiated because a microorganism was found inside the vials. The affected product is identified by Manufacturer's Batch Code F17272 and Lot/Unit Number DUP.
The recalled product was distributed directly to Pennsylvania, Wisconsin, Ohio, Georgia, Nebraska, and California. The product is packaged in plastic bags labeled "DandleLION MEDICAL DandleLION KISSES ORAL USE ONLY SINGLE PATIENT USE SINGLE APPLICATION 24% ORGANIC SUCROSE, D-12442 2mL." Case labeling indicates "DandleLION MEDICAL D 12242 C384 DandleLION KISSES (2ML) 24% ORGANIC SUCROSE SOLUTION ORANGE VIAL QTY - 384."
Consumers and healthcare providers should check their inventory for this specific batch code and discontinue use of the affected vials. The U.S. Food and Drug Administration has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- 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)
- Manufacturer
- Tarry Medical Products, Inc.
- Category
- Drug — Oral Solution
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot/Unit Numbers: DUP Manufacturer's Batch Code: F17272
Distribution
Related recalls
Same manufacturer · Tarry Medical Products, Inc.
See all →- SevereTarry Medical Recalls DandleLION Kisses Due to Microbial Contamination
FDA (Food) · 2016-05-04
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See all →- HighCysto-Urethroscope Disinfection Process Failure Affects Serial Numbers Since 2018
FDA (Devices) · 2022-05-18
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