Why it was recalled
Microorganism found inside vial.
Product description
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 numbers, UPCs & expiration codes
Lot/Unit Numbers: DUP Manufacturer's Batch Code: F17272
Where it was sold
Direct to PA, WI, OH, GA, NE, CA
What to do if you have this product
- Compare the brand, size, and lot/UPC codes on your package with the codes above.
- If it matches, don't eat it. Return it to the store for a refund or throw it away.
- Wash surfaces and containers that touched the product.
- If you feel sick after eating it, contact your doctor. In an emergency call 911.
Recall details
- Recall number
- F-0058-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 20, 2018
- FDA report date
- Oct 24, 2018
- Quantity
- 46 cases (17664 vials)
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Tarry Medical Products, Inc.
Original FDA data
Every field from FDA enforcement report F-0058-2019, exactly as published.
Show all FDA fields
- City
- Danbury
- State
- CT
- Status
- Terminated
- Country
- United States
- Event ID
- 81082
- Address
- 22 Shelter Rock Ln Ste 36
- Code information
- Lot/Unit Numbers: DUP Manufacturer's Batch Code: F17272
- Postal code
- 06810-8267
- Report date
- Oct 24, 2018
- Product type
- Food
- Recall number
- F-0058-2019
- Classification
- Class II
- Recalling firm
- Tarry Medical Products, Inc.
- Product quantity
- 46 cases (17664 vials)
- Termination date
- Nov 29, 2018
- Reason for recall
- Microorganism found inside vial.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Direct to PA, WI, OH, GA, NE, CA
- Recall initiation date
- Sep 20, 2018
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Oct 22, 2018