F-1685-2022 Class II Terminated
Recall Details
- Product Type
- Food
- Report Date
- September 7, 2022
- Initiation Date
- July 19, 2022
- Termination Date
- March 20, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10,922 boxes (250 vials/box) total
Product Description
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
Reason for Recall
Firm received complaints of leaking, black liquid, and black particulates in the product vials.
Distribution Pattern
Nationwide - all 48 states plus Washington DC and Puerto Rico. Australia and United Arab Emirates (Dubai).
Code Information
VPSU15032250 21029a 03/31/2023 VPSU15032250 21031a 03/31/2023