Food product
Sweetums 24% sucrose solution with preservative. Vials containing 1ml or 2ml of 24% sucrose in purified water. Product is administered by drop using vials and tip allows controlled administration directly to tongue or buccal surface. Product is only used in the hospital setting including the NICU. -VPSU15032250, 1mL vial, bagged qty 250
F-1685-2022
Product summary
- Event
- Event 90607
- Status
- Terminated
- Classification
- Class II
- Quantity
- 10,922 boxes (250 vials/box) total
- Official record key
food-enforcement:F-1685-2022
Official wording
Reason: Firm received complaints of leaking, black liquid, and black particulates in the product vials.
Code information: VPSU15032250 21029a 03/31/2023 VPSU15032250 21031a 03/31/2023
Distribution pattern: Nationwide - all 48 states plus Washington DC and Puerto Rico. Australia and United Arab Emirates (Dubai).
Derived failure modes
-
Foreign material or chemical contamination
particulates